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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00884507
Ethics application status
Date submitted
17/04/2009
Date registered
17/04/2009
Date last updated
1/11/2016

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Caba
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Canada
State/province [17] 0 0
Saskatchewan
Country [18] 0 0
France
State/province [18] 0 0
Montpellier
Country [19] 0 0
France
State/province [19] 0 0
Nice
Country [20] 0 0
France
State/province [20] 0 0
St Herblain
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
Germany
State/province [22] 0 0
Günzburg
Country [23] 0 0
Germany
State/province [23] 0 0
Leipzig
Country [24] 0 0
Germany
State/province [24] 0 0
München
Country [25] 0 0
Germany
State/province [25] 0 0
Nürnberg
Country [26] 0 0
Italy
State/province [26] 0 0
Campania
Country [27] 0 0
Italy
State/province [27] 0 0
Lombardia
Country [28] 0 0
Mexico
State/province [28] 0 0
Aguascalientes
Country [29] 0 0
Mexico
State/province [29] 0 0
Guadalajara
Country [30] 0 0
Mexico
State/province [30] 0 0
Monterrey
Country [31] 0 0
Mexico
State/province [31] 0 0
Saltillo
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Leszno
Country [34] 0 0
Poland
State/province [34] 0 0
Torun
Country [35] 0 0
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
Country [38] 0 0
Slovakia
State/province [38] 0 0
Michalovce
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Girona
Country [41] 0 0
Spain
State/province [41] 0 0
Vizcaya
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Malaga
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Blackpool
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Bradford
Country [46] 0 0
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/show/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
Other publications