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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00675090




Registration number
NCT00675090
Ethics application status
Date submitted
24/04/2008
Date registered
8/05/2008

Titles & IDs
Public title
Bridging Study With GSK239512 In Patients With Mild To Moderate Alzheimer's Disease
Scientific title
A Single Blind, Placebo-controlled, Randomised Study in Mild to Moderate Alzheimer's Disease Patients to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK239512, a Selective Histamine H3 Receptor Antagonist
Secondary ID [1] 0 0
H3B109689
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK239512
Treatment: Drugs - Placebo

Experimental: GSK239512 - GSK239512 oral tablets

Placebo comparator: Placebo - Placebo to match tablets


Treatment: Drugs: GSK239512
GSK239512 oral tablets once a day

Treatment: Drugs: Placebo
Placebo tablets to match once a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability as measured by adverse events, vital signs clinical laboratory measurements and validated clinical assessment scales.
Timepoint [1] 0 0
Days 8, 15, 22 and 29
Secondary outcome [1] 0 0
Pharmacodynamics measured by computerized cognitive tests and validated clinical rating scales. Also investigating the Pharmacokineticsat trough concentrations (Cmin) after GSK239512 repeat dosing on days 8, 15, 22 and 29 and 15.
Timepoint [1] 0 0
days 8, 15, 22 and 29

Eligibility
Key inclusion criteria
* Male or female subjects with a clinical diagnosis of probable Alzheimer's disease
* The subject has an MMSE score at screening of 12 to 26 for Part A and 16-26 for Part B.
* Age = 50 and above.
* If female, the subject must be post-menopausal (i.e. 12 months without menstrual period) or surgically sterile.
* Male subjects must be willing to abstain from sexual intercourse with pregnant or lactating women; or be willing to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant, from the time of the first dose of GSK239512 until 84 days following completion of the study.
* The subject has the ability to comply with the study procedures.
* The subject has a permanent caregiver and is willing to attend all study visits for Parts A and B.
* The subject has provided full written informed consent prior to the performance of any protocol specific procedure, or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
* The caregiver has provided his / her written consent prior to the performance of any protocol specific procedure.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* In the opinion of the investigator, following review of CT/MRI scans in the past 12 months and completion of neurological review there could be other probable causes of dementia
* History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, or current depression (a score of =8 on the Cornell Scale for Depression in Dementia), or subjects with other psychiatric features in their AD which would in the opinion of the investigator, would increase risk to safety.
* History of significant sleep disturbance, for example, when it is associated with nocturnal wandering, nocturnal confusion / disorientation / agitation, which in the opinion of the investigator, may increase safety risk.
* History or presence of known or suspected seizures, unexplained significant loss of consciousness within last 6 months. Subjects who had febrile seizures in childhood may be included if these ceased by age 10 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications.
* History or presence of significant cardiovascular, gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
* History of alcohol or other substance abuse, according to the Diagnostic and Statistical Manual of Mental Disorders - Substance related disorders (DSM-IV) criteria.
* Clinically significant abnormalities in laboratory tests, including subjects with active liver disease or uncontrolled thyroid disease.
* Uncontrolled hypertension with systolic BP =160 and/or diastolic =95 mmHg. Subjects with controlled hypertension with systolic BP < 160 mmHg and diastolic <95 mmHg for at least 4 weeks are acceptable.
* Systolic BP <100 mmHg and/or diastolic <60 mmHg.
* Subjects with ECG criteria outside ranges specified in the protocol
* History of hypersensitivity to GSK239512 or its excipients.
* Treatment with cholinesterase inhibitors, (including Tacrine), memantine or selegiline within the previous month. No patients with AD who are already on these medications at the time of screening will be recruited, as it would be unethical to withdraw these medications for study participation. Only AD subjects who are not yet on these medications, or who have withdrawn from these medications for other reasons previously, may be enrolled into this study.
* Subjects who are currently taking or who have taken in the last month anti-psychotic drugs (typical or atypical dopaminergic antagonists or modulators) or mood stabilization drugs (including SSRI, DNRI, SNRI, MAO inhibitors, tricyclic antidepressants, lithium, valproate, carbamazepine).
* Subjects who are currently taking Pgp inhibitors or any CYP3A4 inhibitors.
* Subjects on chronic sedative medications (= 4 days per week for the past 4 weeks).
* Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff.
* Has received any other investigational treatment in the previous 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/06/2009
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Heidelberg Heights
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Prague 10
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Cambridgeshire
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Southall

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00675090