Alzheimer's Disease Education and Referral Center

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

Overall Status:

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 Age	Max Age	Gender	Healthy 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	City	State	Zip Code	Status	Primary Contact
Geolocation is 33.8469812, -117.9541894	Anaheim	California	92801	Recruiting	Name: Phone:
Geolocation is 33.9041552, -117.9307584	Fullerton	California	92835	Recruiting	Name: Phone:
Geolocation is 33.7922392, -118.3150722	Lomita	California	90717	Recruiting	Name: Phone:
Geolocation is 32.8102534, -117.1323579	San Diego	California	92123	Recruiting	Name: Phone:
Geolocation is 37.7929789, -122.4212424	San Francisco	California	94109	Not yet recruiting	Name: Phone:
Geolocation is 34.0448583, -118.4484367	Santa Monica	California	90025	Recruiting	Name: Phone:
Geolocation is 41.3052226, -72.9268626	New Haven	Connecticut	06510	Recruiting	Name: Phone:
Geolocation is 41.1339818, -73.4062342	Norwalk	Connecticut	06851	Recruiting	Name: Phone:
Geolocation is 26.3424842, -80.1149414	Boca Raton	Florida	33486	Recruiting	Name: Phone:
Geolocation is 28.5552719, -82.3878709	Brooksville	Florida	34601	Recruiting	Name: Phone:
Geolocation is 26.4647478, -80.109357	Delray Beach	Florida	33445	Recruiting	Name: Phone:
Geolocation is 26.1897731, -80.1037721	Ft. Lauderdale	Florida	33308	Recruiting	Name: Phone:
Geolocation is 25.778647, -80.2962385	Miami	Florida	33126	Not yet recruiting	Name: Phone:
Geolocation is 25.8207159, -80.1819268	Miami	Florida	33137	Not yet recruiting	Name: Phone:
Geolocation is 25.8223198, -80.289495	Miami Springs	Florida	33166	Recruiting	Name: Phone:
Geolocation is 28.94905, -81.2976011	Orange City	Florida	3273	Recruiting	Name: Phone:
Geolocation is 28.5085825, -81.3564411	Orlando	Florida	32806	Recruiting	Name: Phone:
Geolocation is 27.8756643, -82.6537455	St Petersburg	Florida	33716	Terminated	Name: Phone:
Geolocation is 27.9407591, -82.5104655	Tampa	Florida	33609	Recruiting	Name: Phone:
Geolocation is 26.7619563, -80.1037721	West Palm Beach	Florida	33407	Recruiting	Name: Phone:
Geolocation is 33.8992049, -84.3016021	Atlanta	Georgia	30341	Not yet recruiting	Name: Phone:
Geolocation is 33.8092255, -84.2805478	Decatur	Georgia	30033	Not yet recruiting	Name: Phone:
Geolocation is 42.0039178, -87.9703461	Elk Grove Village	Illinois	60007	Not yet recruiting	Name: Phone:
Geolocation is 29.9335739, -90.0326531	New Orleans	Louisiana	70114	Not yet recruiting	Name: Phone:
Geolocation is 32.4850095, -93.7308152	Shreveport	Louisiana	71104-2136	Recruiting	Name: Phone:
Geolocation is 44.7630567, -85.6206317	Traverse City	Michigan	49684	Not yet recruiting	Name: Phone:
Geolocation is 31.3271189, -89.2903392	Hattiesburg	Mississippi	39401	Recruiting	Name: Phone:
Geolocation is 38.6608855, -90.422618	Creve Coeur	Missouri	63141	Recruiting	Name: Phone:
Geolocation is 40.2962222, -74.0509725	Eatontown	New Jersey	07724	Recruiting	Name: Phone:
Geolocation is 35.1590068, -106.5760857	Albuquerque	New Mexico	87109	Completed	Name: Phone:
Geolocation is 40.74727, -73.9800645	New York	New York	10016	Recruiting	Name: Phone:
Geolocation is 40.555548, -74.1827119	Staten Island	New York	10312	Recruiting	Name: Phone:
Geolocation is 35.8019142, -78.6875364	Raleigh	North Carolina	27607-6520	Not yet recruiting	Name: Phone:
Geolocation is 36.0564654, -80.3324514	Winston-salem	North Carolina	27103	Recruiting	Name: Phone:
Geolocation is 35.5424793, -97.5518056	Oklahoma City	Oklahoma	73116	Recruiting	Name: Phone:
Geolocation is 35.5135639, -97.5788975	Oklahoma City	Oklahoma	73112	Recruiting	Name: Phone:
Geolocation is 45.505603, -122.6882145	Portland	Oregon	97201	Not yet recruiting	Name: Phone:
Geolocation is 40.0959438, -75.1251743	Jenkintown	Pennsylvania	19046	Recruiting	Name: Phone:
Geolocation is 40.329537, -75.9652117	Wyomissing	Pennsylvania	19610	Not yet recruiting	Name: Phone:
Geolocation is 41.8164902, -71.3646236	East Providence	Rhode Island	02914	Recruiting	Name: Phone:
Geolocation is 41.816736, -71.4091563	Providence	Rhode Island	02903	Recruiting	Name: Phone:
Geolocation is 32.785895, -79.9479496	Charleston	South Carolina	29425	Recruiting	Name: Phone:
Geolocation is 32.737615, -97.3840729	Fort Worth	Texas	76107	Not yet recruiting	Name: Phone:
Geolocation is 49.8439404, -124.5194137	Powell River	British Columbia	V8A 3B6	Recruiting	Name: Phone:
Geolocation is 49.2650543, -123.2459921	Vancouver	British Columbia	V6T 2B5	Recruiting	Name: Phone:
Geolocation is 48.4314591, -123.3274789	Victoria	British Columbia	V8R 1J8	Recruiting	Name: Phone:
Geolocation is 44.6442296, -63.5877498	Halilfax	Nova Scotia	B3H 2E1	Recruiting	Name: Phone:
Geolocation is 45.0836805, -64.497142	Kentville	Nova Scotia	B4N 4K9	Recruiting	Name: Phone:
Geolocation is 43.391789, -79.8217953	Burlington	Ontario	L7M 4Y1	Recruiting	Name: Phone:
Geolocation is 45.432491, -75.6965931	Ottawa	Ontario	K1N 5C8	Recruiting	Name: Phone:
Geolocation is 44.3104356, -78.3207436	Peterborough	Ontario	K9H 3S1	Recruiting	Name: Phone:
Geolocation is 43.7585342, -79.3535081	Toronto	Ontario	M3B 2S7	Recruiting	Name: Phone:
Geolocation is 43.7215696, -79.3768256	Toronto	Ontario	M4N 3M5	Recruiting	Name: Phone:
Geolocation is 43.698592, -79.4751345	Toronto	Ontario	M6M 3Z5	Recruiting	Name: Phone:
Geolocation is 45.4248921, -75.7406004	Gatineau	Quebec	J9A 1K7	Recruiting	Name: Phone:
Geolocation is 45.4808565, -73.4666522	Greenfield Park	Quebec	J4V 2J2	Recruiting	Name: Phone:
Geolocation is 45.4044545, -71.9138376	Sherbrooke	Quebec	J1J 3H5	Recruiting	Name: Phone:
Geolocation is 45.4420201, -73.5800493	Verdun	Quebec	H4H 1R3	Recruiting	Name: Phone:
Geolocation is 46.8371449, -71.226169	Quebec	None	G1J 1Z4	Not yet recruiting	Name: Phone:

Agency
Hoffmann-La Roche

Facility Investigators:

Role	Affiliation
Study Director	Hoffmann-La Roche

Study Contact:

Name	Phone	Email
Genentech	888-662-6728 (U.S. only)	genentechclinicaltrials@druginfo.com

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:

August 2015

Disease Stage:

Middle

Enrollment:

420

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

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

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