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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/NCT01677754
Registration number
NCT01677754
Ethics application status
Date submitted
30/08/2012
Date registered
3/09/2012
Date last updated
30/05/2017
Titles & IDs
Public title
A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy
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Scientific title
A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to Background Alzheimer's Disease Therapy in Patients With Moderate Severity Alzheimer's Disease
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Secondary ID [1]
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2012-000943-29
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Secondary ID [2]
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BP28248
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Universal Trial Number (UTN)
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Trial acronym
MAyflOwer RoAD
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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 - RO4602522
Treatment: Drugs - Placebo
Treatment: Drugs - Donepezil
Treatment: Drugs - Memantine
Treatment: Drugs - Rivastigmine
Treatment: Drugs - Galantamine
Placebo Comparator: Placebo - Participants will receive placebo as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
Experimental: RO4602522 1 milligram (mg) - Participants will receive RO4602522 1 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
Experimental: RO4602522 5 mg - Participants will receive RO4602522 5 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
Treatment: Drugs: RO4602522
Participants will receive RO4602522 orally once daily for 12 months.
Treatment: Drugs: Placebo
Participants will receive placebo for RO4602522 orally once daily for 12 months.
Treatment: Drugs: Donepezil
Stable dose as background medication
Treatment: Drugs: Memantine
Stable dose as background medication in combination with AChEIs
Treatment: Drugs: Rivastigmine
Stable dose as background medication
Treatment: Drugs: Galantamine
Stable dose as background medication
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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 Behavior Subscale (ADAS-Cog-11) Score at Month 12
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Assessment method [1]
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Timepoint [1]
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Baseline, Month 12
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Secondary outcome [1]
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Percentage of Participants Achieving Response, Defined as an Increase From Baseline of Less Than or Equal to (<=) 4 Points in ADAS-Cog-11
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Assessment method [1]
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Timepoint [1]
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Baseline, Month 12
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Secondary outcome [2]
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Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Scale Score at Month 12
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Assessment method [2]
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Timepoint [2]
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Baseline, Month 12
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Secondary outcome [3]
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Change From Baseline in Behavioral Pathology in Alzheimer's Disease Frequency-Weighted Severity Scale (BEHAVE-AD-FW) Score at Month 12
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Assessment method [3]
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Timepoint [3]
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Baseline, Month 12
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Secondary outcome [4]
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Percentage of Participants With Worsening in BEHAVE-AD-FW Score
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Assessment method [4]
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Timepoint [4]
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Baseline to Month 12
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Secondary outcome [5]
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Change From Baseline in Apathy Evaluation Scale (AES) Score at 12 months
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Assessment method [5]
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Timepoint [5]
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Baseline, Month 12
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Secondary outcome [6]
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Change From Baseline in Alzheimer's Disease Cooperative Study Clinician Global Impression of Change (ADCS-CGIC) Scale Score at 12 months
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Assessment method [6]
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Timepoint [6]
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Baseline, Month 12
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Secondary outcome [7]
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Percentage of Participants With Worsening in ADCS-CGIC Score
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Assessment method [7]
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Timepoint [7]
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Baseline to Month 12
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Secondary outcome [8]
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Change From Baseline in Global Deterioration Scale (GDS) Score at 12 months
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Assessment method [8]
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Timepoint [8]
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Baseline, Month 12
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Secondary outcome [9]
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Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at 12 months
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Assessment method [9]
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Timepoint [9]
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Baseline, Month 12
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Secondary outcome [10]
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Percentage of Participants with Adverse Events
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Assessment method [10]
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Timepoint [10]
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Baseline up to 13 months
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Secondary outcome [11]
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Percentage of Participants with Change in Lens Opacity Grading
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Assessment method [11]
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Timepoint [11]
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Baseline; Months 6, and 12
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Secondary outcome [12]
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Percentage of Participants with Abnormal Visual Acuity Test Results
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Assessment method [12]
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Timepoint [12]
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Baseline, Months 6, and 12
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Secondary outcome [13]
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Change From Baseline in Michigan Neuropathy Screening Instrument Score
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Assessment method [13]
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Timepoint [13]
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Baseline, Weeks 8, 18, 30, 44, 52, and at the last follow-up visit (12 weeks after last dose, up to 64 weeks)
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Secondary outcome [14]
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Percentage of Participants Receiving Concomitant Medications
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Assessment method [14]
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Timepoint [14]
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Baseline to 13 Months
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Secondary outcome [15]
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Apparent Total Clearance of the Drug From Plasma After Administration of RO4602522
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Assessment method [15]
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Timepoint [15]
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Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
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Secondary outcome [16]
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Apparent Volume of Distribution at Steady State after Administration of RO4602522
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Assessment method [16]
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Timepoint [16]
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Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
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Secondary outcome [17]
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Area Under the Plasma Concentration-Time Curve of RO4602522
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Assessment method [17]
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Timepoint [17]
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Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
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Secondary outcome [18]
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Maximum Plasma Concentration of RO4602522
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Assessment method [18]
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Timepoint [18]
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Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
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Eligibility
Key inclusion criteria
- Probable Alzheimer disease, based on the National Institute of Neurological and
Communicative Disorders and Stroke (NINCDS)/Alzheimer's Disease and Related Disorders
Association (ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Fourth
Edition (DSM-IV-TR) criteria
- Mini-Mental State Exam (MMSE) score at screening between 13 and 20, inclusive
- Body mass index (BMI) between 18 and 36 kilograms per square meter (kg/m^2)
(inclusive) at screening
- Modified Hachinski Ischemia Score of less than or equal to (</=) 4
- Participants with Cornell Scale for Depression in Dementia (CSDD) scores </= 13 at
screening
- Receiving treatment with donepezil, rivastigmine, galantamine or any AChEIs in
combination with memantine for at least 4 months before screening, with their dose and
formulation stabilized at least 3 months before screening. All formulation and dosages
are allowed except donezepil 23 mg (alone or in combination)
- Females of childbearing potential must have a negative pregnancy test and must agree
to use effective contraception
- Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane)
- Have a reliable caregiver or some other identified responsible person who has frequent
contact with the participant
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Minimum age
50
Years
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Maximum age
90
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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
- Any neurological or psychiatric condition that may occur currently or during the
course of the study that can impair cognition or functioning that is not associated
with Alzheimer's disease
- Background of mental retardation
- Uncontrolled behavioral symptoms incompatible with compliance or evaluability
- Alcohol and/or substance abuse or dependence (DSM-IV-TR) in the past 2 years, except
nicotine use which is allowed. However, smokers treated with nicotine replacement
therapy or bupropion are excluded
- Unstable or poorly controlled hypertension as assessed by the investigator regardless
of whether or not the participant is taking antihypertensive medications
- Unstable or clinically significant cardiovascular disease that could be expected to
progress, recur, or change during study period to such an extent that it could bias
the assessment of the clinical or mental status of the participant
- Inadequate hepatic, renal or thyroid function
- Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- Poorly controlled diabetes (glycosylated hemoglobin [HbA1c] greater than or equal to
[>/=] 9 percent at screening)
- Requiring nursing home care. Participants living in assisted living facilities are
allowed if a reliable caregiver is available (see inclusion criteria)
- Current treatment for Alzheimer's disease other than those listed in inclusion
criteria
- Participation at any time in an active Alzheimer's disease vaccine study
- Participation in a passive Alzheimer's disease immunization study less than 1 year
before screening except for a) participants where documented medical history indicate
that they were randomized to the placebo group in these studies, b) participants
treated with bapineuzumab where a 6-month exclusion period applies
- Recent (</= 12 weeks) or concomitant use of other Monoamine oxidase inhibitors
(selective or not) including selegiline or rasagiline
- Antidepressant treatments are not allowed except for citalopram up to 20 mg daily,
escitalopram up to 10 mg daily, paroxetine up to 30 mg daily, sertraline up to 100 mg
daily and trazodone up to 100 mg daily. If treated with one of these antidepressants,
the treatment should be present for at least 6 weeks at screening. All other
antidepressants including other SSRIs, tricyclic antidepressants (TCAs),
serotonin-norepinephrine reuptake inhibitors (SNRIs), St. John's wort and bupropion
are excluded
- Anti-psychotic use within 4 weeks before screening is not permitted except risperidone
up to 1.5 mg/day, quetiapine up to 100 milligrams per day (mg/day), olanzapine up to 5
mg/day, and aripiprazole up to 10 mg daily
- Anxiolytics/ hypnotics use is not permitted except for benzodiazepines of short or
intermediate half-life for anxiety/sleeping disorders. Zolpidem (up to 5 mg/day),
zopiclone (up to 7.5 mg/day), eszopiclone (up to 2 mg/day), trazodone (up to 50
mg/day, at bedtime) or zaleplon (up to 5 mg/day) is permitted for insomnia
- Anti-Parkinson's agents within 2 weeks before screening are not permitted
- Recent (less than 4 weeks prior to screening) or concomitant use of anticonvulsants
- Anticholinergics/ antihistaminics within 2 weeks before screening are not permitted,
except i) if used episodically more than 3 days before the screening cognitive
measurement, ii) non-sedating antihistaminic medications (without anticholinergic
effects such as cetirizine) or peripheral anticholinergics without central
anticholinergic effects (such as, trospium for the treatment of hyperactive bladder),
which are permitted
- Recent (less than 1 week prior to screening) or concomitant use of opioid drugs
(tramadol, methadone, propoxyphene, or meperidine), cyclobenzaprine and
dextromethorphan
- Concomitant use of sympathomimetic drugs, including sympathomimetics in local
anesthetics and ephedra supplements
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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
24/10/2012
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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
12/06/2015
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Sample size
Target
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Accrual to date
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Final
542
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [2]
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Central Coast Neurosciences Research - Erina
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Recruitment hospital [3]
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Southern Neurology - Kogarah
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Recruitment hospital [4]
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Queen Elizabeth Hospital - Woodville
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Recruitment hospital [5]
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Box Hill Hospital; Eastern Clinical Research Unit - Box Hill
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Recruitment hospital [6]
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A.G.Mander Pty Ltd - Geelong
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Recruitment hospital [7]
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Heidelberg Repatriation Hospital - Heidelberg
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Recruitment hospital [8]
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Hollywood Specialist Centre - Nedlands
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Recruitment hospital [9]
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Neurodegenerative Disorders Research - Subiaco
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2250 - Erina
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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5011 - Woodville
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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3084 - Heidelberg
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment postcode(s) [9]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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California
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Connecticut
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Florida
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Busan
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Incheon
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Sopot
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Warszawa
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Alicante
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Barcelona
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Palencia
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Sevilla
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Spain
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Vizcaya
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Albacete
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Valencia
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Sweden
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State/province [72]
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Malmö
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Country [73]
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Sweden
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State/province [73]
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Stockholm
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Country [74]
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United Kingdom
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State/province [74]
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Crowborough
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Country [75]
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United Kingdom
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State/province [75]
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Dundee
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Country [76]
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United Kingdom
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State/province [76]
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Glasgow
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Country [77]
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United Kingdom
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State/province [77]
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Isleworth
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Country [78]
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United Kingdom
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State/province [78]
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London
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Country [79]
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United Kingdom
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State/province [79]
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Norwich
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Country [80]
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United Kingdom
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State/province [80]
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Plymouth
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Country [81]
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United Kingdom
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State/province [81]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
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Summary
Brief summary
This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled
study will evaluate the efficacy and safety of RO4602522 in participants with moderate
severity Alzheimer's disease. Participants who are taking background therapy of
acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4
months before screening will be randomized to receive either one of two doses of RO4602522 or
placebo for 12 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01677754
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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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Clinical Trials
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Hoffmann-La Roche
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01677754
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