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: 
Active, not recruiting
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 CodeStatusPrimary Contact

Geolocation is 33.8469812, -117.9541894

Site
Anaheim
California
92801
Name:
Phone:

Geolocation is 33.9041552, -117.9307584

Site
Fullerton
California
92835
Name:
Phone:

Geolocation is 33.7922392, -118.3150722

Site
Lomita
California
90717
Name:
Phone:

Geolocation is 32.8102534, -117.1323579

Site
San Diego
California
92123
Name:
Phone:

Geolocation is 37.7929789, -122.4212424

Site
San Francisco
California
94109
Name:
Phone:

Geolocation is 34.0448583, -118.4484367

Site
Santa Monica
California
90025
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Name:
Phone:

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Name:
Phone:

Geolocation is 26.3424842, -80.1149414

Site
Boca Raton
Florida
33486
Name:
Phone:

Geolocation is 28.5552719, -82.3878709

Site
Brooksville
Florida
34601
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Name:
Phone:

Geolocation is 26.1897731, -80.1037721

Site
Ft. Lauderdale
Florida
33308
Name:
Phone:

Geolocation is 25.8223198, -80.289495

Site
Miami Springs
Florida
33166
Name:
Phone:

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Name:
Phone:

Geolocation is 28.94905, -81.2976011

Site
Orange City
Florida
3273
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Name:
Phone:

Geolocation is 27.8756643, -82.6537455

Site
St Petersburg
Florida
33716
Name:
Phone:

Geolocation is 27.9407591, -82.5104655

Site
Tampa
Florida
33609
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Name:
Phone:

Geolocation is 33.8092255, -84.2805478

Site
Decatur
Georgia
30033
Name:
Phone:

Geolocation is 33.7748275, -84.2963123

Site
Decatur
Georgia
30030
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Name:
Phone:

Geolocation is 29.9335739, -90.0326531

Site
New Orleans
Louisiana
70114
Name:
Phone:

Geolocation is 32.4850095, -93.7308152

Site
Shreveport
Louisiana
71104-2136
Name:
Phone:

Geolocation is 44.7630567, -85.6206317

Site
Traverse City
Michigan
49684
Name:
Phone:

Geolocation is 31.3271189, -89.2903392

Site
Hattiesburg
Mississippi
39401
Name:
Phone:

Geolocation is 38.6608855, -90.422618

Site
Creve Coeur
Missouri
63141
Name:
Phone:

Geolocation is 40.2962222, -74.0509725

Site
Eatontown
New Jersey
07724
Name:
Phone:

Geolocation is 35.1590068, -106.5760857

Site
Albuquerque
New Mexico
87109
Name:
Phone:

Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Name:
Phone:

Geolocation is 40.555548, -74.1827119

Site
Staten Island
New York
10312
Name:
Phone:

Geolocation is 35.8019142, -78.6875364

Site
Raleigh
North Carolina
27607-6520
Name:
Phone:

Geolocation is 36.0564654, -80.3324514

Site
Winston-salem
North Carolina
27103
Name:
Phone:

Geolocation is 35.5424793, -97.5518056

Site
Oklahoma City
Oklahoma
73116
Name:
Phone:

Geolocation is 35.5135639, -97.5788975

Site
Oklahoma City
Oklahoma
73112
Name:
Phone:

Geolocation is 40.0959438, -75.1251743

Site
Jenkintown
Pennsylvania
19046
Name:
Phone:

Geolocation is 40.329537, -75.9652117

Site
Wyomissing
Pennsylvania
19610
Name:
Phone:

Geolocation is 41.8164902, -71.3646236

Site
East Providence
Rhode Island
02914
Name:
Phone:

Geolocation is 41.816736, -71.4091563

Site
Providence
Rhode Island
02903
Name:
Phone:

Geolocation is 32.785895, -79.9479496

Site
Charleston
South Carolina
29425
Name:
Phone:

Geolocation is 32.737615, -97.3840729

Site
Fort Worth
Texas
76107
Name:
Phone:

Geolocation is 49.8439404, -124.5194137

Site
Powell River
British Columbia
V8A 3B6
Name:
Phone:

Geolocation is 49.2650543, -123.2459921

Site
Vancouver
British Columbia
V6T 2B5
Name:
Phone:

Geolocation is 48.4314591, -123.3274789

Site
Victoria
British Columbia
V8R 1J8
Name:
Phone:

Geolocation is 44.6442296, -63.5877498

Site
Halilfax
Nova Scotia
B3H 2E1
Name:
Phone:

Geolocation is 45.0836805, -64.497142

Site
Kentville,
Nova Scotia
B4N 4K9
Name:
Phone:

Geolocation is 43.391789, -79.8217953

Site
Burlington
Ontario
L7M 4Y1
Name:
Phone:

Geolocation is 45.432491, -75.6965931

Site
Ottawa
Ontario
K1N 5C8
Name:
Phone:

Geolocation is 44.3104356, -78.3207436

Site
Peterborough
Ontario
K9H 3S1
Name:
Phone:

Geolocation is 43.7215696, -79.3768256

Site
Toronto
Ontario
M4N3M5
Name:
Phone:

Geolocation is 43.698592, -79.4751345

Site
Toronto
Ontario
M6M 3Z5
Name:
Phone:

Geolocation is 43.7585342, -79.3535081

Site
Toronto
Ontario
M3B 2S7
Name:
Phone:

Geolocation is 45.4827785, -75.6872156

Site
Gatineau
Quebec
J8T 8J1
Name:
Phone:

Geolocation is 45.4808565, -73.4666522

Site
Greenfield Park
Quebec
J4V 2J2
Name:
Phone:

Geolocation is 45.4044545, -71.9138376

Site
Sherbrooke
Quebec
J1J 3H5
Name:
Phone:

Geolocation is 45.4420201, -73.5800493

Site
Verdun
Quebec
H4H 1R3
Name:
Phone:

Geolocation is 46.8371449, -71.226169

Site
Quebec
None
G1J 1Z4
Name:
Phone:
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