Alzheimer's Disease Education and Referral Center

MK-8931 for Amnestic Mild Cognitive Impairment

MK-8931 for Amnestic Mild Cognitive Impairment

Overall Status: 
Recruiting
Brief Description: 

This Phase III trial will assess the efficacy and safety of the experimental drug MK-8931 to treat people with amnestic mild cognitive impairment (aMCI) due to Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
85 Years
Both
No
Inclusion Criteria: 
    • Diagnosis of amnestic MCI (prodromal Alzheimer's disease), including:
      • History of subjective memory decline with gradual onset and slow progression for at least 1 year, corroborated by someone who knows the participant well
      • Objective impairment in episodic memory, as determined by test results at screening
      • No dementia
    • Positive result of brain imaging (amyloid PET scan) or cerebrospinal fluid test (tau:amyloid-β42 ratio)
    • Ability to read at a 6th grade level or equivalent
    • If taking Alzheimer's medication, must be on stable dose for at least 3 months before screening
    • Reliable, competent study partner who has a close relationship with the participant, is willing to accompany him or her to all trial visits, and can ensure administration of the trial medication
Exclusion Criteria: 
    • History of stroke
    • Evidence of a clinically relevant neurological disorder other than aMCI
    • History of seizures or epilepsy within the last 5 years
    • Evidence of a clinically relevant or unstable psychiatric disorder, excluding major depression in remission; participant is at imminent risk of self-harm or harm to others
    • History of alcoholism or drug dependency/abuse within the last 5 years
    • Contraindication to magnetic resonance imaging scan or PET scan, including claustrophobia or excessive weight
    • History of hepatitis or active liver disease within the past 6 months
    • Recent or ongoing, uncontrolled, clinically significant medical condition within the last 3 months
    • History of malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or localized prostate carcinoma
    • Clinically significant vitamin B12 or folate deficiency within the last 6 months
    • Use of any investigational drugs or participation in any other clinical trial within 30 days before screening
    • History of a hypersensitivity reaction to more than three drugs
    • History of human immunodeficiency virus (HIV)
    • Body Mass Index of less than 18 or more than 35
    • History or current evidence of long QT syndrome, corrected QT (QTc) interval of at least 470 milliseconds (for male participants) or at least 480 milliseconds (for female participants), or torsades de pointes
Detailed Description: 

In this trial, participants will be randomized to take either one of two doses of MK-8931 or a placebo for 2 years. MK-8931, a tablet taken once daily, is believed to help prevent the formation of amyloid plaques, harmful protein deposits in the brain that are a main sign of Alzheimer's disease.

Two substudies are included, but participants are not required to take part in a substudy to be part of the larger trial. In one substudy, participants will undergo PET medical imaging using a tracer, [18F]flutemetamol, to evaluate changes in amyloid in the brain. In the other substudy, investigators will evaluate response to treatment in participants who have amyloid and certain forms of another protein, tau, in cerebrospinal fluid.

Central Contact Information: 

For more information about this trial, please call Merck Sharp & Dohme at 1-888-577-8839.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.3650631, -111.7495419

Site
Gilbert
Arizona
85234
Recruiting
Name:
Phone:

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Recruiting
Name:
Phone:

Geolocation is 33.5080943, -112.0863874

Site
Phoenix
Arizona
85013
Recruiting
Name:
Phone:

Geolocation is 33.5910441, -111.7972384

Site
Scottsdale
Arizona
85259
Recruiting
Name:
Phone:

Geolocation is 33.612697, -112.280129

Site
Sun City
Arizona
85351
Recruiting
Name:
Phone:

Geolocation is 36.1192532, -94.0388918

Site
Fayetteville
Arkansas
72703
Recruiting
Name:
Phone:

Geolocation is 34.1583323, -118.5155901

Site
Encino
California
91316
Recruiting
Name:
Phone:

Geolocation is 33.9041552, -117.9307584

Site
Fullerton
California
92835
Recruiting
Name:
Phone:

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Recruiting
Name:
Phone:

Geolocation is 38.5800184, -121.4627576

Site
Sacramento
California
95816
Recruiting
Name:
Phone:

Geolocation is 34.1423899, -118.4571974

Site
Sherman Oaks
California
91403
Recruiting
Name:
Phone:

Geolocation is 34.2774306, -118.7897558

Site
Simi Valley
California
93065
Recruiting
Name:
Phone:

Geolocation is 37.424106, -122.1660756

Site
Stanford
California
94305
Recruiting
Name:
Phone:

Geolocation is 34.1633045, -118.3841777

Site
Valley Village
California
91607
Recruiting
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Recruiting
Name:
Phone:

Geolocation is 38.9079086, -77.0716829

Site
Washington
District of Columbia
20057
Recruiting
Name:
Phone:

Geolocation is 26.5273497, -81.8333656

Site
Fort Myers
Florida
33912
Recruiting
Name:
Phone:

Geolocation is 25.8925211, -80.3352364

Site
Hialeah
Florida
33016
Recruiting
Name:
Phone:

Geolocation is 26.0197012, -80.1819268

Site
Hollywood
Florida
33021
Recruiting
Name:
Phone:

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name:
Phone:

Geolocation is 25.8176795, -80.1372757

Site
Miami Beach
Florida
33140
Recruiting
Name:
Phone:

Geolocation is 26.132433, -81.7951054

Site
Naples
Florida
34102
Recruiting
Name:
Phone:

Geolocation is 29.1571921, -82.1223977

Site
Ocala
Florida
34471
Recruiting
Name:
Phone:

Geolocation is 29.2858129, -81.0558894

Site
Ormond Beach
Florida
32174
Recruiting
Name:
Phone:

Geolocation is 26.8598894, -80.0870155

Site
Palm Beach Gardens
Florida
33410
Recruiting
Name:
Phone:

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name:
Phone:

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name:
Phone:

Geolocation is 33.828105, -84.3279093

Site
Atlanta
Georgia
30329
Recruiting
Name:
Phone:

Geolocation is 41.8816606, -87.6926257

Site
Chicago
Illinois
60612
Recruiting
Name:
Phone:

Geolocation is 39.0609319, -95.7247169

Site
Topeka
Kansas
66606
Recruiting
Name:
Phone:

Geolocation is 30.4192451, -91.1448981

Site
Baton Rouge
Louisiana
70808
Recruiting
Name:
Phone:

Geolocation is 39.3744588, -76.745195

Site
Baltimore
Maryland
21208
Recruiting
Name:
Phone:

Geolocation is 44.9737443, -93.0817473

Site
Saint Paul
Minnesota
55130
Recruiting
Name:
Phone:

Geolocation is 40.9259319, -74.6348828

Site
Mt. Arlington
New Jersey
07856
Recruiting
Name:
Phone:

Geolocation is 40.0207099, -74.2061931

Site
Toms River
New Jersey
08755
Recruiting
Name:
Phone:

Geolocation is 40.7978787, -73.6995749

Site
Manhasset
New York
11030
Recruiting
Name:
Phone:

Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Recruiting
Name:
Phone:

Geolocation is 41.0464858, -73.9495818

Site
Orangeburg
New York
10962
Recruiting
Name:
Phone:

Geolocation is 43.1301942, -77.6020569

Site
Rochester
New York
14620
Recruiting
Name:
Phone:

Geolocation is 43.0915814, -77.6421577

Site
Rochester
New York
14623
Recruiting
Name:
Phone:

Geolocation is 40.555548, -74.1827119

Site
Staten Island
New York
10312
Recruiting
Name:
Phone:

Geolocation is 40.8540649, -81.460856

Site
Canton
Ohio
44718
Recruiting
Name:
Phone:

Geolocation is 39.9990626, -83.0173386

Site
Columbus
Ohio
43210
Recruiting
Name:
Phone:

Geolocation is 41.4739419, -81.5370671

Site
Shaker Heights
Ohio
44122
Recruiting
Name:
Phone:

Geolocation is 35.5135639, -97.5788975

Site
Oklahoma City
Oklahoma
73112
Recruiting
Name:
Phone:

Geolocation is 36.142324, -95.956825

Site
Tulsa
Oklahoma
74104
Recruiting
Name:
Phone:

Geolocation is 45.5478224, -122.7288206

Site
Portland
Oregon
97210
Recruiting
Name:
Phone:

Geolocation is 45.5064511, -122.7756216

Site
Portland
Oregon
97225
Recruiting
Name:
Phone:

Geolocation is 40.1373404, -75.3761952

Site
Norristown
Pennsylvania
19403
Recruiting
Name:
Phone:

Geolocation is 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Recruiting
Name:
Phone:

Geolocation is 41.2737475, -75.8359645

Site
Plains
Pennsylvania
18705
Recruiting
Name:
Phone:

Geolocation is 40.1439985, -75.1157286

Site
Willow Grove
Pennsylvania
19090
Recruiting
Name:
Phone:

Geolocation is 41.8396817, -71.3883751

Site
Providence
Rhode Island
02906
Recruiting
Name:
Phone:

Geolocation is 32.7791432, -79.9248669

Site
Charleston
South Carolina
29401
Recruiting
Name:
Phone:

Geolocation is 36.548434, -82.5618186

Site
Kingsport
Tennessee
37660
Recruiting
Name:
Phone:

Geolocation is 36.1523805, -86.7893889

Site
Nashville
Tennessee
37203
Recruiting
Name:
Phone:

Geolocation is 32.8798071, -96.7547522

Site
Dallas
Texas
75231
Recruiting
Name:
Phone:

Geolocation is 38.0293059, -78.4766781

Site
Charlottesville
Virginia
22903
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 Sharp & Dohme Corp.
Collaborator Sponsor: 
Facility Investigators: 
Study Contact: 
NamePhoneEmail
Merck Sharp & Dohme Corp.
1-888-577-8839
Locations
 
 
ClinicalTrials.gov ID 
NCT01953601 (follow link to view full record on ct.gov in new window)
Official Title: 
A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects With Amnestic Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal AD)
Study Start Date: 
November 2013
Study End Date: 
March 2018
Disease Stage: 
Early
Enrollment: 
1500