Back to resultsA Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
RO5313534
RO5313534
RO5313534
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
RO5313534 15mg
RO5313534 1mg
RO5313534 5mg
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Secondary Outcome Measures
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00884507
Brief Title
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
RO5313534 15mg
Arm Type
Experimental
Arm Title
RO5313534 1mg
Arm Type
Experimental
Arm Title
RO5313534 5mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
RO5313534
Intervention Description
1mg po daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
RO5313534
Intervention Description
5mg po daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
RO5313534
Intervention Description
15mg po daily for 24 weeks
Primary Outcome Measure Information:
Title
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
Time Frame
At intervals up to week 24, then at week 28
Title
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
Time Frame
At intervals to week 24, then at week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
City
Ft Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-4706
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1090AAH
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
City
Caba
ZIP/Postal Code
C1126AAB
Country
Argentina
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Medicine Hat
State/Province
Alberta
ZIP/Postal Code
T1A-4C2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nice
ZIP/Postal Code
06003
Country
France
City
St Herblain
ZIP/Postal Code
44800
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Günzburg
ZIP/Postal Code
89312
Country
Germany
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
City
München
ZIP/Postal Code
80331
Country
Germany
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Castellanza
State/Province
Lombardia
ZIP/Postal Code
21053
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44610
Country
Mexico
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
City
Saltillo
ZIP/Postal Code
25000
Country
Mexico
City
Gdansk
ZIP/Postal Code
80-282
Country
Poland
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
City
Torun
ZIP/Postal Code
87-100
Country
Poland
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
City
Bucharest
ZIP/Postal Code
041914
Country
Romania
City
Bucharest
ZIP/Postal Code
Sect 4
Country
Romania
City
Bratislava
ZIP/Postal Code
825 56
Country
Slovakia
City
Michalovce
ZIP/Postal Code
071 01
Country
Slovakia
City
BArcelon
State/Province
Barcelona
ZIP/Postal Code
08034
Country
Spain
City
Salt
State/Province
Girona
ZIP/Postal Code
17090
Country
Spain
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Blackpool
ZIP/Postal Code
FY20JH
Country
United Kingdom
City
Bradford
ZIP/Postal Code
BD30DQ
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO30 3JB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
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