An Efficacy and Safety Trial of Verubecestat (MK-8931) in Mild to Moderate Alzheimer's Disease (P07738)

Description

The purpose of this study is to assess the efficacy and safety of MK-8931 compared with placebo in the treatment of Alzheimer's Disease (AD). The primary study hypotheses are that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score and that at least one MK-8931 dose is superior to placebo at 78 weeks of treatment with respect to change from Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score.

Study Start Date

November 2012

Estimated Completion Date

July 2019

Interventions

  • Drug: MK-8931 (Part I and Part II)
  • Drug: Verubecestat (Part I and Part II)
  • Drug: Verubecestat (Part II)
  • Drug: MK-8931 (Part II)
  • Drug: MK-8931
  • Drug: Placebo
  • Drug: Placebo (Part I)

Specialties

  • Internal Medicine: Neurology
  • Neurology: Dementia
  • Physician Assistant: Neurology

MeSH Terms

  • Alzheimer Disease
  • QT syndrome

Study ID

Merck -- P07738

Status

Unknown

Trial ID

NCT01739348

Study Type

Interventional

Trial Phase

Phase 2/Phase 3

Enrollment Quota

1960

Sponsor

Merck

Inclusion Criteria

  • Diagnosis of probable AD based on both a) the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria and b) the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for AD
  • AD is of mild to moderate severity
  • Clear history of cognitive and functional decline over at least one year that is either a) documented in medical records or b) documented by history from an informant who knows the subject well
  • Able to read at a 6th grade level or equivalent, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation
  • If a participant is receiving an acetylcholinesterase inhibitor, memantine and/or herbal medications for AD, the dose must have been stable for at least three months before Screening, and the participant must be willing to remain on the same dose for the duration of the trial
  • Participant must have a reliable and competent trial partner/caregiver who must have a close relationship with the subject

Exclusion Criteria

  • History of stroke
  • Evidence of a neurological disorder other than the disease being studied (ie, probable AD)
  • History of seizures or epilepsy within the last 5 years before Screening
  • Evidence of a clinically relevant or unstable psychiatric disorder, excluding major depression in remission
  • Participant is at imminent risk of self-harm or of harm to others
  • History of alcoholism or drug dependency/abuse within the last 5 years before Screening
  • Participant is unwilling or not eligible to undergo a magnetic resonance imaging (MRI) scan
  • History of hepatitis or liver disease that has been active within the six months prior to Screening Visit
  • Recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of the Screening Visit (e.g., diabetes, hypertension, thyroid or endocrine disease, congestive heart failure, angina, cardiac or gastrointestinal disease, dialysis, or abnormal renal function) other than the condition being studied such that participation in the trial would pose a significant medical risk to the subject. Controlled co-morbid conditions are not exclusionary if stable within three months of the Screening Visit
  • History or current evidence of long QT syndrome, corrected QT (QTc) interval ?470 milliseconds (for male subjects) or ?480 milliseconds (for female subjects), or torsades de pointes
  • History of malignancy occurring within the five years before Screening, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or localized prostate carcinoma
  • or malignancy which has been treated with potentially curative therapy with no evidence of recurrence for ?3 year post-therapy
  • Clinically significant vitamin B12 or folate deficiency in the six months before Screening Visit
  • Use of any investigational drugs or participation in any other clinical trial within the 30 days before Screening Visit
  • History of a hypersensitivity reaction to more than three drugs
  • Has tested positive for human immunodeficiency virus (HIV)
  • Close family member (including the caregiver) who is among the personnel of the investigational or sponsor staff directly involved with this trial Additional Exclusion Criteria for Safety Cohort (first approximately 400 participants entering trial):
  • History of an ongoing medical condition that has been poorly controlled within 6 months of the Screening Visit (e.g., syncope, hypotension, diabetes, hypertension, cerebrovascular disease, thyroid disease, endocrine disturbance, congestive heart failure, cardiac or gastrointestinal disease, dialysis, or abnormal renal function) other than the condition being studied such that a subject's participation in the trial would pose a significant medical risk
  • History of congestive heart failure (moderate or greater severity), myocardial infarction, heart surgery, syncope, bradycardia, or clinically significant hypotension within one year before Screening

Gender

Both

Ages

55 Years to 85 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (56)

Study Location Distance Name Phone Email
Call for Information Investigational Site 0060 - Providence, Rhode Island 39.6 miles None None None
Call for Information Investigational Site 0078 - New Haven, Connecticut 119.2 miles None None None
Call for Information Investigational Site 1061 - Manhasset, New York 172.2 miles None None None
Call for Information Investigational Site 1106 - Orangeburg, New York 173.9 miles None None None
Call for Information Investigational Site 0061 - New York, New York 183.2 miles None None None
Call for Information Investigational Site 1089 - New York, New York 184.8 miles None None None
Call for Information Investigational Site 0026 - New York, New York 186.5 miles None None None
Call for Information Investigational Site 0020 - Staten Island, New York 203.5 miles None None None
Call for Information Investigational Site 0054 - Toms River, New Jersey 230.7 miles None None None
Call for Information Investigational Site 1117 - Pennington, New Jersey 237.3 miles None None None
Call for Information Investigational Site 1074 - Plains, Pennsylvania 256.3 miles None None None
Call for Information Investigational Site 0081 - Willow Grove, Pennsylvania 259.6 miles None None None
Call for Information Investigational Site 0089 - Rochester, New York 334.7 miles None None None
Call for Information Investigational Site 0039 - Rochester, New York 335.8 miles None None None
Call for Information Investigational Site 0040 - Baltimore, Maryland 358.9 miles None None None
Call for Information Investigational Site 0077 - Washington, District of Columbia 394.6 miles None None None
Call for Information Investigational Site 0062 - Richmond, Virginia 475.0 miles None None None
Call for Information Investigational Site 0033 - Shaker Heights, Ohio 539.9 miles None None None
Call for Information Investigational Site 0010 - Canton, Ohio 545.3 miles None None None
Call for Information Investigational Site 1064 - Durham, North Carolina 608.4 miles None None None
Call for Information Investigational Site 0013 - Charlotte, North Carolina 723.1 miles None None None
Call for Information Investigational Site 0049 - Kingsport, Tennessee 731.8 miles None None None
Call for Information Investigational Site 0006 - Cincinnati, Ohio 737.9 miles None None None
Call for Information Investigational Site 1084 - Charleston, South Carolina 821.3 miles None None None
Call for Information Investigational Site 1119 - Chicago, Illinois 849.5 miles None None None
Call for Information Investigational Site 0064 - Chicago, Illinois 851.3 miles None None None
Call for Information Investigational Site 0029 - Elk Grove Village, Illinois 868.2 miles None None None
Call for Information Investigational Site 0046 - Atlanta, Georgia 930.3 miles None None None
Call for Information Investigational Site 1070 - Madison, Wisconsin 932.2 miles None None None
Call for Information Investigational Site 0045 - Nashville, Tennessee 942.8 miles None None None
Call for Information Investigational Site 1068 - Saint Louis, Missouri 1,037.4 miles None None None
Call for Information Investigational Site 1099 - Ormond Beach, Florida 1,064.8 miles None None None
Call for Information Investigational Site 0058 - Ocala, Florida 1,101.1 miles None None None
Call for Information Investigational Site 1107 - Saint Paul, Minnesota 1,112.4 miles None None None
Call for Information Investigational Site 0018 - Orlando, Florida 1,118.6 miles None None None
Call for Information Investigational Site 1092 - Tampa, Florida 1,177.4 miles None None None
Call for Information Investigational Site 1120 - Delray Beach, Florida 1,214.3 miles None None None
Call for Information Investigational Site 1109 - Bolivar, Missouri 1,225.0 miles None None None
Call for Information Investigational Site 0063 - Hollywood, Florida 1,244.0 miles None None None
Call for Information Investigational Site 0059 - Hallandale Beach, Florida 1,245.7 miles None None None
Call for Information Investigational Site 0025 - Kansas City, Missouri 1,252.6 miles None None None
Call for Information Investigational Site 0015 - Fairway, Kansas 1,252.9 miles None None None
Call for Information Investigational Site 0031 - Hialeah, Florida 1,256.3 miles None None None
Call for Information Investigational Site 0047 - Fayetteville, Arkansas 1,305.8 miles None None None
Call for Information Investigational Site 0071 - Topeka, Kansas 1,307.7 miles None None None
Call for Information Investigational Site 0043 - Baton Rouge, Louisiana 1,385.0 miles None None None
Call for Information Investigational Site 0055 - Tulsa, Oklahoma 1,394.9 miles None None None
Call for Information Investigational Site 0027 - Oklahoma City, Oklahoma 1,495.7 miles None None None
Call for Information Investigational Site 0074 - Dallas, Texas 1,545.0 miles None None None
Call for Information Investigational Site 0076 - Dallas, Texas 1,546.8 miles None None None
Call for Information Investigational Site 0004 - Murray, Utah 2,100.2 miles None None None
Call for Information Investigational Site 0065 - Gilbert, Arizona 2,285.1 miles None None None
Call for Information Investigational Site 0070 - Phoenix, Arizona 2,296.9 miles None None None
Call for Information Investigational Site 0084 - La Jolla, California 2,583.7 miles None None None
Call for Information Investigational Site 0050 - Fountain Valley, California 2,590.7 miles None None None
Call for Information Investigational Site 0053 - Long Beach, California 2,600.0 miles None None None

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