Alzheimer's Disease Education and Referral Center

MK-8931 for Mild to Moderate Alzheimer's Disease

MK-8931 for Mild to Moderate Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

This Phase II/III study will assess the safety and efficacy of the experimental drug MK-8931 compared with a placebo as a possible treatment for Alzheimer's disease. Three different doses will be tested 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 Alzheimer's disease based on both NINCDS-ADRDA criteria and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision criteria
    • Alzheimer's of mild to moderate severity
    • Clear history of cognitive and functional decline over at least 1 year that is either documented in medical records or documented by a person who knows the subject well
    • Able to read at a 6th grade level or equivalent; must have a history of academic achievement and/or employment sufficient to exclude mental retardation
    • If taking medications for Alzheimer's, including herbal supplements, must be on stable dose for at least 3 months before screening; must be willing to remain on the same dose for the duration of the trial
    • Reliable, competent partner/caregiver who has a close relationship with the participant
Exclusion Criteria: 

    All Participants

    • Evidence of a neurological disorder other than probable Alzheimer's disease; history of stroke; history of seizures or epilepsy within the past 5 years
    • Evidence of a clinically relevant or unstable psychiatric disorder, excluding major depression in remission; at imminent risk of self-harm or harm to others
    • History of alcohol or drug dependence or abuse within the past 5 years
    • Unwilling or unable to undergo a magnetic resonance imaging (MRI) scan
    • History of active hepatitis or liver disease within the past 6 months
    • Uncontrolled, clinically significant medical condition within 3 months of the screening visit (for example, diabetes, hypertension, thyroid or endocrine disease, congestive heart failure, angina, cardiac or gastrointestinal disease, dialysis, abnormal renal function) that would pose a significant medical risk to the subject; controlled co-morbid conditions are not exclusionary if stable within 3 months of the screening visit
    • History or current evidence of long QT syndrome; corrected QT (QTc) interval at least 470 milliseconds (for male subjects) or at least 480 milliseconds (for female subjects); torsades de pointes
    • History of malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized prostate carcinoma, or malignancy that has been treated with potentially curative therapy with no evidence of recurrence for 3 years or longer
    • Clinically significant vitamin B12 or folate deficiency within the past 6 months
    • Use of investigational drugs or participation in any other clinical trial within 30 days before the screening visit
    • History of hypersensitivity to more than three drugs
    • Tested positive for human immunodeficiency virus (HIV)

     Additional Exclusion Criteria for Safety Cohort

    For the first 400 participants entering this trial:

    • Ongoing medical condition that has been poorly controlled within 6 months of the screening visit (for example, syncope, hypotension, diabetes, hypertension, cerebrovascular disease, thyroid disease, endocrine disturbance, congestive heart failure, cardiac or gastrointestinal disease, dialysis, or abnormal renal function) that would pose a significant medical risk during the trial
    • History of congestive heart failure (moderate or greater severity), myocardial infarction, heart surgery, syncope, bradycardia, or clinically significant hypotension within 1 year before screening
Detailed Description: 

An enzyme called beta-secretase leads to harmful deposits of a protein, beta-amyloid, in the brains of people with Alzheimer's disease. The drug tested in this study, MK-8931, is thought to inhibit beta-secretase and prevent the formation of beta-amyloid plaques. Three different doses of the drug, a tablet taken once daily, will be compared to a placebo to gauge its effects on people with mild to moderate Alzheimer's disease. Outcomes include scores on tests of cognitive status and daily functioning.

The study consists of two parts. Part I will assess the efficacy and safety of MK-8931 compared with a placebo administered for 78 weeks (about 18 months) to treat Alzheimer's disease. Participants who complete Part I may choose to participate in Part II, a long-term study that will assess the efficacy and safety of MK-8931 for up to an additional 260 weeks (5 years).

Part I includes two substudies. The first substudy is a medical imaging substudy to evaluate changes in brain amyloid using positron emission tomography (PET) and an amyloid tracer. The second substudy is a cerebrospinal fluid (CSF) biomarker substudy to evaluate changes in CSF concentrations of beta-amyloid-related peptides, total tau, and phosphorylated tau (p-tau). The substudies will be conducted only at designated investigational sites. Participants are not required to take part in a substudy to take part in the larger trial.

Central Contact Information: 

For more information about this trial and study sites, call Merck toll-free at 888-577-8839.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Recruiting
Name:
Phone:

Geolocation is 33.5910441, -111.7972384

Site
Scottsdale
Arizona
85259
Recruiting
Name:
Phone:

Geolocation is 36.1192532, -94.0388918

Site
Fayetteville
Arkansas
72703
Recruiting
Name:
Phone:

Geolocation is 33.7091847, -117.9536697

Site
Fountain Valley
California
92708
Recruiting
Name:
Phone:

Geolocation is 33.9041552, -117.9307584

Site
Fullerton
California
92835
Recruiting
Name:
Phone:

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
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 34.1633045, -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 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 25.8223198, -80.289495

Site
Miami Springs
Florida
33166
Recruiting
Name:
Phone:

Geolocation is 29.1571921, -82.1223977

Site
Ocala
Florida
34471
Recruiting
Name:
Phone:

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
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 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 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Recruiting
Name:
Phone:

Geolocation is 39.0222277, -94.6319018

Site
Fairway
Kansas
66205
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 42.2808256, -83.7430378

Site
Ann Arbor
Michigan
48105-2945
Recruiting
Name:
Phone:

Geolocation is 38.9546734, -94.5985613

Site
Kansas City
Missouri
64114
Recruiting
Name:
Phone:

Geolocation is 38.6160491, -90.2291565

Site
Saint Louis
Missouri
63104
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 40.7916407, -73.9447994

Site
New York
New York
10029
Recruiting
Name:
Phone:

Geolocation is 40.7700703, -73.9580246

Site
New York
New York
10021
Recruiting
Name:
Phone:

Geolocation is 40.7764882, -73.4673454

Site
Plainview
New York
11803
Recruiting
Name:
Phone:

Geolocation is 43.0915814, -77.6421577

Site
Rochester
New York
14623
Recruiting
Name:
Phone:

Geolocation is 43.1301942, -77.6020569

Site
Rochester
New York
14620
Recruiting
Name:
Phone:

Geolocation is 40.555548, -74.1827119

Site
Staten Island
New York
10312
Recruiting
Name:
Phone:

Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Recruiting
Name:
Phone:

Geolocation is 36.025609, -78.9853813

Site
Durham
North Carolina
27705
Recruiting
Name:
Phone:

Geolocation is 40.8540649, -81.460856

Site
Canton
Ohio
44718
Recruiting
Name:
Phone:

Geolocation is 39.1269228, -84.514354

Site
Cincinnati
Ohio
45219
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 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Recruiting
Name:
Phone:

Geolocation is 39.9559288, -75.1574567

Site
Philadelphia
Pennsylvania
19107
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 41.816736, -71.4091563

Site
Providence
Rhode Island
02903
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 32.824251, -96.7440467

Site
Dallas
Texas
75214
Recruiting
Name:
Phone:

Geolocation is 29.7050857, -95.4018087

Site
Houston
Texas
77030
Recruiting
Name:
Phone:

Geolocation is 40.6609843, -111.9164779

Site
Murray
Utah
84123
Recruiting
Name:
Phone:

Geolocation is 40.7834328, -111.7376178

Site
Salt Lake City
Utah
84108
Recruiting
Name:
Phone:

Geolocation is 37.5735567, -77.5218127

Site
Richmond
Virginia
23226
Recruiting
Name:
Phone:

Geolocation is 43.0772547, -89.430773

Site
Madison
Wisconsin
53792
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
888-577-8839
Locations
 
 
ClinicalTrials.gov ID 
Official Title: 
A Randomized, Placebo Controlled, Parallel-Group, Double Blind Efficacy and Safety Trial of MK-8931 in Subjects With Mild to Moderate Alzheimer's Disease (Protocol No. MK-8931-017-03)(Also Known as SCH 900931, P07738)
Study Start Date: 
November 2012
Study End Date: 
April 2017
Disease Stage: 
Early
Middle
Enrollment: 
1960