Alzheimer's Disease Education and Referral Center

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 for 18 months.

Patient Qualifications:

Min Age	Max Age	Gender	Healthy 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.

Two substudies are included in the study protocol. The first is a medical imaging substudy to evaluate changes in brain amyloid using positron emission tomography (PET) and an amyloid tracer. The second 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	City	State	Zip Code	Status	Primary Contact
Geolocation is 33.4754919, -112.3924311	Goodyear	Arizona	85395	Recruiting	Name: Phone:
Geolocation is 33.4636012, -112.0535987	Phoenix	Arizona	85006	Recruiting	Name: Phone:
Geolocation is 36.1192532, -94.0388918	Fayetteville	Arkansas	72703	Recruiting	Name: Phone:
Geolocation is 33.7091847, -117.9536697	Fountain Valley	California	92708	Recruiting	Name: Phone:
Geolocation is 33.9041552, -117.9307584	Fullerton	California	92835	Recruiting	Name: Phone:
Geolocation is 33.8065036, -118.1912538	Long Beach	California	90806	Recruiting	Name: Phone:
Geolocation is 38.5800184, -121.4627576	Sacramento	California	95816	Recruiting	Name: Phone:
Geolocation is 34.1633045, -118.3841777	Valley Village	California	91607	Recruiting	Name: Phone:
Geolocation is 41.3052226, -72.9268626	New Haven	Connecticut	06510	Recruiting	Name: Phone:
Geolocation is 38.9079086, -77.0716829	Washington	District of Columbia	20057	Recruiting	Name: Phone:
Geolocation is 26.1514248, -80.2265545	Fort Lauderdale	Florida	33313	Recruiting	Name: Phone:
Geolocation is 25.9812024, -80.148379	Hallandale Beach	Florida	33009	Recruiting	Name: Phone:
Geolocation is 26.0197012, -80.1819268	Hollywood	Florida	33021	Recruiting	Name: Phone:
Geolocation is 29.1571921, -82.1223977	Ocala	Florida	34471	Recruiting	Name: Phone:
Geolocation is 28.5085825, -81.3564411	Orlando	Florida	32806	Recruiting	Name: Phone:
Geolocation is 26.8598894, -80.0870155	Palm Beach Gardens	Florida	33410	Recruiting	Name: Phone:
Geolocation is 28.0869646, -82.4698603	Tampa	Florida	33613	Recruiting	Name: Phone:
Geolocation is 33.828105, -84.3279093	Atlanta	Georgia	30329	Recruiting	Name: Phone:
Geolocation is 41.8816606, -87.6926257	Chicago	Illinois	60612	Recruiting	Name: Phone:
Geolocation is 39.0222277, -94.6319018	Fairway	Kansas	66205	Recruiting	Name: Phone:
Geolocation is 39.0609319, -95.7247169	Topeka	Kansas	66606	Recruiting	Name: Phone:
Geolocation is 30.4192451, -91.1448981	Baton Rouge	Louisiana	70808	Recruiting	Name: Phone:
Geolocation is 39.3744588, -76.745195	Baltimore	Maryland	21208	Recruiting	Name: Phone:
Geolocation is 38.9546734, -94.5985613	Kansas City	Missouri	64114	Recruiting	Name: Phone:
Geolocation is 40.2962222, -74.0509725	Eatontown	New Jersey	07724	Recruiting	Name: Phone:
Geolocation is 40.0207099, -74.2061931	Toms River	New Jersey	08755	Recruiting	Name: Phone:
Geolocation is 40.7978787, -73.6995749	Manhasset	New York	11030	Recruiting	Name: Phone:
Geolocation is 40.74727, -73.9800645	New York	New York	10016	Recruiting	Name: Phone:
Geolocation is 40.7764882, -73.4673454	Plainview	New York	11803	Recruiting	Name: Phone:
Geolocation is 43.0915814, -77.6421577	Rochester	New York	14623	Recruiting	Name: Phone:
Geolocation is 43.1301942, -77.6020569	Rochester	New York	14620	Recruiting	Name: Phone:
Geolocation is 40.555548, -74.1827119	Staten Island	New York	10312	Recruiting	Name: Phone:
Geolocation is 35.1660032, -80.7934798	Charlotte	North Carolina	28211	Recruiting	Name: Phone:
Geolocation is 41.4644979, -81.5087322	Beachwood	Ohio	44122	Recruiting	Name: Phone:
Geolocation is 40.8540649, -81.460856	Canton	Ohio	44718	Recruiting	Name: Phone:
Geolocation is 39.1269228, -84.514354	Cincinnati	Ohio	45219	Recruiting	Name: Phone:
Geolocation is 35.5135639, -97.5788975	Oklahoma City	Oklahoma	73112	Recruiting	Name: Phone:
Geolocation is 36.142324, -95.956825	Tulsa	Oklahoma	74104	Recruiting	Name: Phone:
Geolocation is 45.5478224, -122.7288206	Portland	Oregon	97210	Recruiting	Name: Phone:
Geolocation is 40.1313817, -75.1370254	Abington	Pennsylvania	19001	Recruiting	Name: Phone:
Geolocation is 39.9583587, -75.1953934	Philadelphia	Pennsylvania	19104	Recruiting	Name: Phone:
Geolocation is 41.2753589, -75.8501955	Plains	Pennsylvania	18705	Recruiting	Name: Phone:
Geolocation is 41.8396817, -71.3883751	Providence	Rhode Island	02906	Recruiting	Name: Phone:
Geolocation is 32.9221152, -80.0367259	Charleston	South Carolina	29406	Recruiting	Name: Phone:
Geolocation is 36.548434, -82.5618186	Kingsport	Tennessee	37660	Recruiting	Name: Phone:
Geolocation is 36.1523805, -86.7893889	Nashville	Tennessee	37203	Recruiting	Name: Phone:
Geolocation is 32.8798071, -96.7547522	Dallas	Texas	75231	Recruiting	Name: Phone:
Geolocation is 32.824251, -96.7440467	Dallas	Texas	75214	Recruiting	Name: Phone:
Geolocation is 40.6609843, -111.9164779	Murray	Utah	84123	Recruiting	Name: Phone:
Geolocation is 37.5735567, -77.5218127	Richmond	Virginia	23226	Recruiting	Name: Phone:
Geolocation is 45.456487, -73.8405569	Kirkland	Quebec	H9H 3L1	Recruiting	Name: Phone:

Agency
Merck

Facility Investigators:

Study Contact:

Name	Phone
Merck	888-577-8839

Locations

ClinicalTrials.gov ID

NCT01739348 (follow link to view full record on ct.gov in new window)

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

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MK-8931 for Mild to Moderate Alzheimer's Disease

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MK-8931 for Mild to Moderate Alzheimer's Disease

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