Alzheimer's Disease Education and Referral Center

RO4602522 in Patients with Moderate Alzheimer Disease on Donepezil or Rivastigmine Therapy

RO4602522 in Patients with Moderate Alzheimer Disease on Donepezil or Rivastigmine Therapy

Overall Status: 
Completed
Brief Description: 

The purpose of this Phase II study is to evaluate the efficacy and safety of RO4602522 in people with moderate-stage Alzheimer disease who have been taking donepezil or rivastigmine for at least 6 months.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
90 Years
Both
No
Inclusion Criteria: 

  • Probable Alzheimer's disease
  • Mini Mental State Examination score of 14-20 inclusive; Modified Hachinski Ischemia Score of 4 or less; Cornell Scale for Depression in Dementia (CSDD) score of 13 or less
  • Body mass index (BMI) between 18 and 36 kg/m2 inclusive
  • Taking donepezil (5 to 10 mg daily) or rivastigmine (4.6 mg daily or 9.5 mg daily patch) for at least 6 months; dose and formulation stable for at least 3 months; participants taking rivastigmine tablets are eligible but must switch to patch during the study
  • Females of childbearing potential must have negative pregnancy test and agree to use effective contraception
  • Generally healthy and ambulatory or ambulatory-aided (walker or cane acceptable)
  • Reliable caregiver or other person who has frequent contact with the participant

Exclusion Criteria: 

  • Any neurological or psychiatric condition not specified in protocol exceptions
  • Mental retardation
  • Uncontrolled behavioral symptoms incompatible with compliance or evaluability
  • Alcohol and/or substance abuse or dependence in the past 2 years, except nicotine use, which is allowed. (Smokers treated with nicotine replacement therapy or bupropion are excluded.)
  • Unstable or poorly controlled hypertension
  • Unstable or clinically significant cardiovascular disease that could progress, recur, or change significantly during study period
  • Inadequate hepatic, renal or thyroid function
  • Positive for hepatitis B, hepatitis C, or HIV infection
  • Poorly controlled diabetes
  • Requires nursing home care
  • Participation at any time in an active Alzheimer's disease vaccine study; participation in a passive Alzheimer's immunization study less than 1 year before screening
  • Prohibited medications: Alzheimer's disease treatment other than donepezil or rivastigmine; psychotropic medication

Detailed Description: 

This Phase II study will evaluate the efficacy and safety of RO4602522 in people with moderate-stage Alzheimer's disease . Participants who are taking donepezil or rivastigmine for at least 6 months before the study begins will be randomized to receive either one of two doses of RO4602522 or a placebo for 12 months.

Central Contact Information: 

For more information about this clinical trial or study sites, please call 1-888-662-6728 (U.S. only) or email  genentechclinicaltrials@druginfo.com. Reference Study ID number BP28248.

Locations: 
Map Marker CityStateZip CodePrimary Contact

Geolocation is 25.8207159, -80.1819268

n/a
Miami
Florida
33137
n/a

Geolocation is 30.035327, -82.8113822

n/a
Orange City
Florida
3273
n/a

Geolocation is 28.5085825, -81.3564411

n/a
Orlando
Florida
32806
n/a

Geolocation is 27.8756643, -82.6537455

n/a
St Petersburg
Florida
33716
n/a

Geolocation is 27.9407591, -82.5104655

n/a
Tampa
Florida
33609
n/a

Geolocation is 26.7619563, -80.1037721

n/a
West Palm Beach
Florida
33407
n/a

Geolocation is 33.7748275, -84.2963123

n/a
Decatur
Georgia
30030
n/a

Geolocation is 33.8092255, -84.2805478

n/a
Decatur
Georgia
30033
n/a

Geolocation is 42.0039178, -87.9703461

n/a
Elk Grove Village
Illinois
60007
n/a

Geolocation is 29.9335739, -90.0326531

n/a
New Orleans
Louisiana
70114
n/a

Geolocation is 32.4850095, -93.7308152

n/a
Shreveport
Louisiana
71104-2136
n/a

Geolocation is 44.7630567, -85.6206317

n/a
Traverse City
Michigan
49684
n/a

Geolocation is 31.3271189, -89.2903392

n/a
Hattiesburg
Mississippi
39401
n/a

Geolocation is 38.6608855, -90.422618

n/a
Creve Coeur
Missouri
63141
n/a

Geolocation is 40.2962222, -74.0509725

n/a
Eatontown
New Jersey
07724
n/a

Geolocation is 35.1590068, -106.5760857

n/a
Albuquerque
New Mexico
87109
n/a

Geolocation is 40.74727, -73.9800645

n/a
New York
New York
10016
n/a

Geolocation is 40.555548, -74.1827119

n/a
Staten Island
New York
10312
n/a

Geolocation is 35.8019142, -78.6875364

n/a
Raleigh
North Carolina
27607-6520
n/a

Geolocation is 36.0564654, -80.3324514

n/a
Winston-salem
North Carolina
27103
n/a

Geolocation is 35.5135639, -97.5788975

n/a
Oklahoma City
Oklahoma
73112
n/a

Geolocation is 35.5424793, -97.5518056

n/a
Oklahoma City
Oklahoma
73116
n/a

Geolocation is 40.0959438, -75.1251743

n/a
Jenkintown
Pennsylvania
19046
n/a

Geolocation is 40.329537, -75.9652117

n/a
Wyomissing
Pennsylvania
19610
n/a

Geolocation is 41.8164902, -71.3646236

n/a
East Providence
Rhode Island
02914
n/a

Geolocation is 41.816736, -71.4091563

n/a
Providence
Rhode Island
02903
n/a

Geolocation is 32.785895, -79.9479496

n/a
Charleston
South Carolina
29425
n/a

Geolocation is 32.737615, -97.3840729

n/a
Fort Worth
Texas
76107
n/a

Geolocation is 49.8439404, -124.5194137

n/a
Powell River
British Columbia
V8A 3B6
n/a

Geolocation is 49.2650543, -123.2459921

n/a
Vancouver
British Columbia
V6T 2B5
n/a

Geolocation is 48.4314591, -123.3274789

n/a
Victoria
British Columbia
V8R 1J8
n/a

Geolocation is 44.6442296, -63.5877498

n/a
Halilfax
Nova Scotia
B3H 2E1
n/a

Geolocation is 45.0836805, -64.497142

n/a
Kentville,
Nova Scotia
B4N 4K9
n/a

Geolocation is 43.391789, -79.8217953

n/a
Burlington
Ontario
L7M 4Y1
n/a

Geolocation is 45.432491, -75.6965931

n/a
Ottawa
Ontario
K1N 5C8
n/a

Geolocation is 44.3104356, -78.3207436

n/a
Peterborough
Ontario
K9H 3S1
n/a

Geolocation is 43.7585342, -79.3535081

n/a
Toronto
Ontario
M3B 2S7
n/a

Geolocation is 43.7173575, -79.3777054

n/a
Toronto
Ontario
M4G 3E8
n/a

Geolocation is 43.7215696, -79.3768256

n/a
Toronto
Ontario
M4N 3M5
n/a

Geolocation is 45.4827785, -75.6872156

n/a
Gatineau
Quebec
J8T 8J1
n/a

Geolocation is 45.4808565, -73.4666522

n/a
Greenfield Park
Quebec
J4V 2J2
n/a

Geolocation is 45.4044545, -71.9138376

n/a
Sherbrooke
Quebec
J1J 3H5
n/a

Geolocation is 45.4420201, -73.5800493

n/a
Verdun
Quebec
H4H 1R3
n/a

Geolocation is 46.8371449, -71.226169

n/a
Quebec
G1J 1Z4
n/a
Lead Sponsor: 
Agency
Hoffmann-La Roche
Collaborator Sponsor: 
Facility Investigators: 
RoleAffiliation
Study Director
Hoffmann-La Roche
Study Contact: 
NamePhoneEmail
Genentech
888-662-6728 (U.S. only)
Locations
 
 
ClinicalTrials.gov ID 
NCT01677754 (follow link to view full record on ct.gov in new window)
Study Start Date: 
November 2012
Study End Date: 
June 2015
Disease Stage: 
Middle
Enrollment: 
420