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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00710684
Registration number
NCT00710684
Ethics application status
Date submitted
30/06/2008
Date registered
4/07/2008
Date last updated
7/12/2017
Titles & IDs
Public title
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
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Scientific title
Study AZ3110866, a Fixed Dose Study of SB-742457 Versus Placebo When Added to Existing Donepezil Treatment in Subjects With Mild-to-moderate Alzheimer's Disease
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Secondary ID [1]
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AZ3110866
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SB-742457 15mg
Treatment: Drugs - SB-742457 35mg
Treatment: Drugs - Placebo
Treatment: Drugs - donepezil 5-10mg
Experimental: DONEPEZIL + SB-742457 15 MG - SB-742457 - 15mg added to existing donepezil treatment
Placebo Comparator: DONEPEZIL + PLACEBO - Placebo added to existing donepezil
Experimental: DONEPEZIL + SB-742457 35 MG - SB-742457 - 35mg added to existing donepezil
Treatment: Drugs: SB-742457 15mg
SB-742457 - 15mg added to existing donepezil treatment
Treatment: Drugs: SB-742457 35mg
SB-742457 - 35mg added to existing donepezil
Treatment: Drugs: Placebo
Placebo added to existing donepezil
Treatment: Drugs: donepezil 5-10mg
existing donepezil treatment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score at Week 24
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Assessment method [1]
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ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the case report form (CRF) for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean is presented.
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Timepoint [1]
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Baseline(Week 0) and Week 24
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Primary outcome [2]
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Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Week 24
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Assessment method [2]
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The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.
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Timepoint [2]
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Baseline(Week 0) and Week 24
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Secondary outcome [1]
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Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24
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Assessment method [1]
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RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.
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Timepoint [1]
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Baseline (Week 0) and Week 24
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Secondary outcome [2]
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Change From Baseline in ADAS-Cog Total Score at Week 12, 36 and 48
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Assessment method [2]
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ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the CRF for questions 3 to 6 and 8 to 11. In cases where more than one question was missing, a total score was not be imputed. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been present
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Timepoint [2]
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Baseline (Week 0) and Week 12, 36 and 48
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Secondary outcome [3]
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Change From Baseline in CDR-SB Score at Week 12, 36 and 48
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Assessment method [3]
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The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.
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Timepoint [3]
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Baseline (Week 0) and Week 12, 36, 48
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Secondary outcome [4]
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Change From Baseline in RBANS Score at Week 12, 36 and 48
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Assessment method [4]
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RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.
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Timepoint [4]
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Baseline (Week 0) and Week 12, 36 and 48
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Secondary outcome [5]
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Change From Baseline in Alzheimer's Disease Co-operative Study Group - Activities of Daily Living Inventory (ADCS- ADL) Total Score at Weeks 12, 24, 36 and 48
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Assessment method [5]
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The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions about the participant. The questions ranged from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signified greater functional ability. The questionnaire was split into two types of questions, an initial question relating to whether a participant had completed a particular activity and then a follow on question which scored how much assistance the participant had required if they had performed that particular activity. The total score was calculated by adding up the responses for each of the individual activities. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.
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Timepoint [5]
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Baseline (Week 0) and Week 12, 24, 36 and 48
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Secondary outcome [6]
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Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 24 and 48
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Assessment method [6]
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The MMSE consisted of 11 items covering orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Scores for each of the 11 individual tests were not recorded on the CRF, therefore if any item was missing then the total score was be set to missing. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.
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Timepoint [6]
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Baseline (Week 0) and Week 24 and 48
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Secondary outcome [7]
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During Treatment Phase
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Assessment method [7]
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An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
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Timepoint [7]
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Up to follow-up i.e. 2 weeks post end of treatment (Week 24, Week 48 or Early Withdrawal)
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Secondary outcome [8]
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Number of Participants With Parameters of Clinical Concern - Hematology
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Assessment method [8]
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Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Eosinophils (high-2), Hematocrit (low- 0.8, high-1.2), Lymphocytes (low-0.75, high-1.5), Mean Corpuscle Hemoglobin (MCH) (low-0.8, high-1.2), Monocytes(low-0.75, high-2), Neutrophil bands (high-10), Platelet count (low-100, high-500), Segmented Neutrophils (low-0.75, high-1.3), Total Neutrophils (low-0.75, high-1.5), and white blood cells (WBC) (low-3, high-15).
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Timepoint [8]
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Up to Week 48
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Secondary outcome [9]
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Number of Participants With Parameters of Clinical Concern - Clinical Chemistry
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Assessment method [9]
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Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Alanine Amino Transferase (ALT) (high-1.5), Alkaline Phosphatase (high-1.5), Aspartate Amino Transferase (ASAT) (high-1.5), BUN/Creatinine ratio (high-1.5), Calcium (low- 0.75, high-1.25), Carbon dioxide content/Bicarbonate (low-15, high- 40), Cholesterol (high-1.25), Creatine Kinase ((low- 0.5, high-1.25), Creatinine (low- 0.5, high-1.25), Direct Bilirubin (high-1.5), Gamma Glutamyl Transferase (GGT) (high-2), Glucose (low- 3.6, high-7.8), HDL Cholesterol (low-0.65), LDL Cholesterol (hig-1.25), Magnesium (low-0.5, high-2), Phosphorus inorganic (low- 0.5, high-1.5), Potassium (low- 3, high-5.5), Sodium (low- 130, high-150), Total Bilirubin (high-1.5), Triglycerides (high -4) and Urea/BUN (high-11).
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Timepoint [9]
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Up to Week 48
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Secondary outcome [10]
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Exposure Estimates for SB-742457 : Area Under the Concentration Time Curve Over the Dosing Interval at Steady State (AUCtss)
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Assessment method [10]
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AUCtss of SB-742457 was estimated via nonlinear mixed effect analysis. This pharmacokinetic(PK) model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.
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Timepoint [10]
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Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48
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Secondary outcome [11]
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Exposure Estimates for SB-742457 : Minimum Concentrations at Steady State (Cmin-ss)
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Assessment method [11]
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Cmin-ss was estimated via nonlinear mixed effect analysis. This PK model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.
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Timepoint [11]
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Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48
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Secondary outcome [12]
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Exposure Estimates for Donepezil (Cavgss)
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Assessment method [12]
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Participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) were allowed to participate in this study. Cavgss for donepezil approximately 12 to 20 hours after dosing were summarized by donepezil dose level 5 mg/7.5 mg/10 mg/15 mg.
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Timepoint [12]
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Post-dose at 12 to 20 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48
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Secondary outcome [13]
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Change From Baseline in ADAS-Cog Scale in Participants With APOE4 Gene
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Assessment method [13]
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Genetic analyses was conducted to assess the effect of APOE4 carriage. ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five-point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores were recorded on the CRF for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.
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Timepoint [13]
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Baseline (Week 0) to Week 24 and Week 48
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Secondary outcome [14]
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Change From Baseline in CDR-SB Scale in Participants With APOE4 Gene
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Assessment method [14]
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Genetic analyses was conducted to assess the effect of APOE4 carriage. The CDR-SB is an interviewer administered scale and impairment is scored in following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment was scored on a scale in which none =0, questionable =0.5, mild =1, moderate =2 and severe =3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher score indicating severe impairment. If there were any missing items then CDR-SB was set to missing and was not imputed. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.
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Timepoint [14]
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Baseline (Week 0) to Week 24 and Week 48
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Secondary outcome [15]
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Change From Baseline in RBANS Scale in Participants With APOE4 Gene
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Assessment method [15]
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Genetic analyses was conducted to assess the effect of APOE4 carriage. RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.
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Timepoint [15]
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Baseline (Week 0) to Week 24 and Week 48
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Eligibility
Key inclusion criteria
- Subjects and their caregivers must provide informed consent prior to study entry.
- Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's
disease with no evidence of disorders that are thought to be the cause of, or
contributing to the severity of the subject's dementia and a documented history of at
least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2
months.
- Subjects must have a regular caregiver who is willing to attend visits, oversee the
subject's compliance with the study and report on the subject's status.
- Female subjects of child-bearing potential must agree to abstinence or an approved
form of birth control.
- Subjects must have adequate blood pressure and laboratory values.
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Minimum age
50
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects with a diagnosis of possible, probable or definite vascular dementia may not
participate.
- Subjects with known hypersensitivity to sunlight or a history of seizures, previous
exposure to SB-742457, taking agents for which there is a theoretical risk of
interaction with SB-742457, or taking medication for Alzheimer's disease or centrally
acting agents which might impact study outcomes may not participate.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/11/2010
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Sample size
Target
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Accrual to date
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Final
682
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Kogarah
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Recruitment hospital [2]
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GSK Investigational Site - Herston
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Recruitment hospital [3]
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GSK Investigational Site - Woodville
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Recruitment hospital [4]
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GSK Investigational Site - Ballarat
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Recruitment hospital [5]
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GSK Investigational Site - Heidelberg West
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Recruitment hospital [6]
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GSK Investigational Site - Kew
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Recruitment hospital [7]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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5011 - Woodville
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Recruitment postcode(s) [4]
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3350 - Ballarat
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Recruitment postcode(s) [5]
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3084 - Heidelberg West
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Recruitment postcode(s) [6]
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3101 - Kew
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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New Jersey
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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Tennessee
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Texas
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United States of America
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State/province [11]
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Vermont
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Argentina
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State/province [12]
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Buenos Aires
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Argentina
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Córdova
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Argentina
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Santa Fe
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Québec
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Chile
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Región Metro De Santiago
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Chile
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Valparaíso
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Chile
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Santiago
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Czechia
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Melnik
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Czechia
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Olomouc
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Czechia
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Ostrava
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Czechia
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Pardubice
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Czechia
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Plzen
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Czechia
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Praha 10
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Czechia
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Praha 1
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Czechia
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Praha 4
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Thueringen
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Germany
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Berlin
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Italy
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Abruzzo
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Italy
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Campania
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Toscana
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Italy
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Umbria
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Italy
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Veneto
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Spain
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Baracaldo/Vizcaya
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Spain
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Barcelona
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Spain
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Burgos
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Spain
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State/province [51]
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Castellón
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Country [52]
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Spain
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Madrid
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Country [53]
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Spain
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Murcia
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Country [54]
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Spain
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Salamanca
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Country [55]
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Spain
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San Sebastián
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Country [56]
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Spain
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State/province [56]
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San Vicente Del Raspeig/Alicante
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Country [57]
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Spain
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State/province [57]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
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Summary
Brief summary
The study is designed to investigate the safety and efficacy of SB-742457 when added to
stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00710684
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00710684
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