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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00884507




Registration number
NCT00884507
Ethics application status
Date submitted
17/04/2009
Date registered
20/04/2009
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
Scientific title
A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease
Secondary ID [1] 0 0
2008-004012-13
Secondary ID [2] 0 0
WN22018
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 - Placebo
Treatment: Drugs - RO5313534
Treatment: Drugs - RO5313534
Treatment: Drugs - RO5313534

Placebo comparator: Placebo -

Experimental: RO5313534 15mg -

Experimental: RO5313534 1mg -

Experimental: RO5313534 5mg -


Treatment: Drugs: Placebo
po daily for 24 weeks

Treatment: Drugs: RO5313534
1mg po daily for 24 weeks

Treatment: Drugs: RO5313534
5mg po daily for 24 weeks

Treatment: Drugs: RO5313534
15mg po daily for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
Timepoint [1] 0 0
At intervals up to week 24, then at week 28
Secondary outcome [2] 0 0
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
Timepoint [2] 0 0
At intervals to week 24, then at week 28

Eligibility
Key inclusion criteria
* adult patients, >/=50 years of age;
* probable Alzheimer's disease;
* MMSE score at screening of 13-22;
* under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline;
* not requiring nursing home care, but looked after by a caregiver/carer.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* dementia due to condition other than Alzheimer's disease;
* other significant neurological disorder;
* untreated/non-stabilized major depressive disorder;
* bipolar disorder, schizophrenia, or any other serious psychiatric condition.

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Parallel
Other design features
Phase
Phase 2
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
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
389
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
- Hornsby
Recruitment hospital [2] 0 0
- Chermside
Recruitment hospital [3] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Kentucky
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
State/province [7] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Oregon
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Argentina
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Buenos Aires
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Argentina
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Caba
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Canada
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Alberta
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Canada
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British Columbia
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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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Saskatchewan
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France
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Montpellier
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France
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Nice
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France
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St Herblain
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France
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Toulouse
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Germany
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Günzburg
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Germany
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Leipzig
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Germany
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München
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Germany
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Nürnberg
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Italy
State/province [26] 0 0
Campania
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Italy
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Lombardia
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Mexico
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Aguascalientes
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Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Saltillo
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Poland
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Gdansk
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Poland
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Leszno
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Poland
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Torun
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Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Romania
State/province [36] 0 0
Bucharest
Country [37] 0 0
Slovakia
State/province [37] 0 0
Bratislava
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Slovakia
State/province [38] 0 0
Michalovce
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Spain
State/province [39] 0 0
Barcelona
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Spain
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Girona
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Spain
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Vizcaya
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Spain
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Madrid
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Spain
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Malaga
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United Kingdom
State/province [44] 0 0
Blackpool
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United Kingdom
State/province [45] 0 0
Bradford
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United Kingdom
State/province [46] 0 0
Glasgow
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00884507
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00884507