Alzheimer's Disease Education and Referral Center

MK-7622 in People with Alzheimer's Disease Taking Donepezil

MK-7622 in People with Alzheimer's Disease Taking Donepezil

Overall Status: 
Recruiting
Brief Description: 

This trial will test the efficacy and safety of MK-7622 as an add-on therapy to donepezil in people with mild to moderate Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
85 Years
Both
No
Inclusion Criteria: 
    • Diagnosis of probable mild to moderate Alzheimer's disease based on both the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria and the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria for AD
    • Clear history of cognitive and functional decline during at least 1 year that is either documented in medical records or history from an informant who knows the participant well
    • Taking a stable dose of 10 mg donepezil daily for at least 3 months before screening; willing to remain on the same dose for the duration of the trial
    • Ability to read at a 6th grade level or equivalent; history of academic achievement and/or employment sufficient to exclude mental retardation
    • Reliable, competent trial partner/caregiver who has a close relationship with the participant
Exclusion Criteria: 
    • Neurological disorder other than probable Alzheimer's disease
    • Clinically relevant or unstable psychiatric disorder, excluding major depression in remission for more than 2 years
    • Major surgery within the past 3 months
    • At imminent risk of self-harm or harm to others
    • History of stroke, seizures or epilepsy within the last 5 years, alcoholism or drug dependency/abuse within the past 5 years, or hepatitis or liver disease that has been active within the past 6 months
    • Inability to undergo a magnetic resonance imaging scan
    • Recent or ongoing uncontrolled, clinically significant medical condition within the past 3 months (such as diabetes, hypertension, thyroid or endocrine disease, congestive heart failure, angina, cardiac or gastrointestinal disease, dialysis, or abnormal renal function) such that participation in the trial would pose a significant medical risk; controlled co-morbid conditions are not exclusionary if stable
    • History or current evidence of long QT syndrome, corrected QT (QTc) interval 470 milliseconds or more (for male subjects) or 80 milliseconds or more (for female subjects), or torsades de pointes
    • History of cancer within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or localized prostate carcinoma that has been treated with potentially curative therapy, with no evidence of recurrence for at least 3 years
    • Clinically significant vitamin B12 deficiency or increased thyroid-stimulating hormone level in the past 6 months.
Detailed Description: 

This Phase II trial will test the experimental drug MK-7622 to see if it improves cognition in people with mild to moderate Alzheimer's disease. The trial consists of two stages. Participants in Stage 1 will be randomized to receive either the test drug or a placebo, a capsule taken once daily, for 26 weeks. Based on the results, the trial may continue into Stage 2, in which a separate group of participants will be randomized to receive either the test drug (5, 15, or 45 mg) or a placebo, taken once daily, for 26 weeks. All participants will receive a placebo at some point during the trial. The primary hypothesis are that MK-7622 is superior to placebo in improving cognition in participants after 12 weeks.

 

Central Contact Information: 

Central Contact: 1-888-577-8839

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Recruiting
Name:
Phone:

Geolocation is 34.7486563, -92.3542193

Site
Little Rock
Arkansas
72205
Recruiting
Name:
Phone:

Geolocation is 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Recruiting
Name:
Phone:

Geolocation is 33.192168, -117.3028803

Site
Oceanside
California
92056
Recruiting
Name:
Phone:

Geolocation is 33.78659, -117.8750976

Site
Orange
California
92868
Recruiting
Name:
Phone:

Geolocation is 34.2054029, -119.1681373

Site
Oxnard
California
93030
Recruiting
Name:
Phone:

Geolocation is 32.8102534, -117.1323579

Site
San Diego
California
92123
Recruiting
Name:
Phone:

Geolocation is 39.732746, -104.9710123

Site
Denver
Colorado
80218
Recruiting
Name:
Phone:

Geolocation is 41.3755722, -73.4533779

Site
Danbury
Connecticut
06810-4088
Recruiting
Name:
Phone:

Geolocation is 41.1948222, -73.28833

Site
Fairfield
Connecticut
06824
Recruiting
Name:
Phone:

Geolocation is 41.4305881, -72.9106202

Site
Hamden
Connecticut
06518
Recruiting
Name:
Phone:

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Recruiting
Name:
Phone:

Geolocation is 38.9178427, -77.0218255

Site
Washington
District of Columbia
20060
Recruiting
Name:
Phone:

Geolocation is 26.3767589, -80.1037721

Site
Boca Raton
Florida
33431
Recruiting
Name:
Phone:

Geolocation is 26.5273497, -81.8333656

Site
Fort Myers
Florida
33912
Recruiting
Name:
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Recruiting
Name:
Phone:

Geolocation is 26.0197012, -80.1819268

Site
Hollywood
Florida
33021
Recruiting
Name:
Phone:

Geolocation is 25.8176795, -80.1372757

Site
Miami Beach
Florida
33140
Recruiting
Name:
Phone:

Geolocation is 26.17785, -80.2711588

Site
Sunrise
Florida
33351
Recruiting
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Recruiting
Name:
Phone:

Geolocation is 30.2310081, -93.2190898

Site
Lake Charles
Louisiana
70629
Recruiting
Name:
Phone:

Geolocation is 42.2513682, -70.9962875

Site
Quincy
Massachusetts
02169
Recruiting
Name:
Phone:

Geolocation is 42.1341459, -72.5707614

Site
Springfield
Massachusetts
01104
Recruiting
Name:
Phone:

Geolocation is 42.2766433, -85.5097226

Site
Kalamazoo
Michigan
49048
Recruiting
Name:
Phone:

Geolocation is 40.3572976, -74.6672226

Site
Princeton
New Jersey
08540
Recruiting
Name:
Phone:

Geolocation is 40.0207099, -74.2061931

Site
Toms River
New Jersey
08755
Recruiting
Name:
Phone:

Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Recruiting
Name:
Phone:

Geolocation is 35.2146586, -80.8599193

Site
Charlotte
North Carolina
28203
Recruiting
Name:
Phone:

Geolocation is 35.8409242, -78.6228504

Site
Raleigh
North Carolina
27609
Recruiting
Name:
Phone:

Geolocation is 35.8019142, -78.6875364

Site
Raleigh
North Carolina
27607
Recruiting
Name:
Phone:

Geolocation is 36.0564654, -80.3324514

Site
Winston-Salem
North Carolina
27103
Recruiting
Name:
Phone:

Geolocation is 39.6400784, -84.1751648

Site
Centerville
Ohio
45459
Recruiting
Name:
Phone:

Geolocation is 39.9990626, -83.0173386

Site
Columbus
Ohio
43210
Recruiting
Name:
Phone:

Geolocation is 39.7383713, -84.2910759

Site
Dayton
Ohio
45417
Recruiting
Name:
Phone:

Geolocation is 40.3014581, -79.5389289

Site
Greensburg
Pennsylvania
15601
Recruiting
Name:
Phone:

Geolocation is 41.8396817, -71.3883751

Site
Providence
Rhode Island
02906
Recruiting
Name:
Phone:

Geolocation is 35.9046545, -86.7718017

Site
Franklin
Tennessee
37067
Recruiting
Name:
Phone:

Geolocation is 32.824251, -96.7440467

Site
Dallas
Texas
75214
Recruiting
Name:
Phone:

Geolocation is 29.5060908, -98.577596

Site
San Antonio
Texas
78229
Recruiting
Name:
Phone:

Geolocation is 33.8954726, -98.544636

Site
Wichita Falls
Texas
76309
Recruiting
Name:
Phone:

Geolocation is 40.4960215, -111.8687825

Site
Draper
Utah
84020
Recruiting
Name:
Phone:

Geolocation is 40.7078639, -111.8508966

Site
Salt Lake City
Utah
84106
Recruiting
Name:
Phone:

Geolocation is 40.6620696, -111.8866683

Site
Salt Lake City
Utah
84107
Recruiting
Name:
Phone:

Geolocation is 40.7834328, -111.7376178

Site
Salt Lake City
Utah
84108-1225
Recruiting
Name:
Phone:

Geolocation is 45.456487, -73.8405569

Site
Kirkland
Quebec
H9H 3L1
Recruiting
Name: Medical Information Centre / Centre de l'information medicale de Merck Canada
Phone: 514-428-8600 / 1-800-567-2594
Lead Sponsor: 
Agency
Merck
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhone
Merck
1-888-577-8839
Locations
 
 
ClinicalTrials.gov ID 
NCT01852110 (follow link to view full record on ct.gov in new window)
Official Title: 
A Seamless Phase IIa/IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of MK-7622 as an Adjunctive Therapy to Donepezil for Symptomatic Treatment in Subjects With Alzheimer's Dise
Study Start Date: 
October 2013
Study End Date: 
May 2017
Disease Stage: 
Early
Middle
Enrollment: 
830