||Merck Sharp & Dohme Corp.
|Amnestic Mild Cognitive Impairment
Prodromal Alzheimer's Disease
||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).|
|Length of Study:
||The study is approximately two years long
|Number of Visits:
||12 study visits
|Ages Eligible for Study:
||50 Years to 85 Years
|Genders Eligible for Study:
- Diagnosis of prodromal AD, including the following:
- History of subjective memory decline with gradual onset and slow progression for at least one year corroborated by an informant,
- Objective impairment in episodic memory by memory test performed at Screening,
- Does not meet criteria for dementia, AND
- Positive Screening amyloid imaging PET scan using [18F]flutametamol tracer or positive Screening CSF tau:amyloid-β42 (Aβ42) ratio.
Able to read at a 6th grade level or equivalent.
- If participant is receiving an acetylcholinesterase inhibitor or memantine, the dose must have been stable for at least three months before Screening.
- Must have a reliable and competent trial partner/informant who has a close relationship with the participant and is willing to accompany the participant to all required trial visits, and to monitor compliance of the administration of the trial medication.
- History of stroke.
- Evidence of a clinically relevant neurological disorder other than the disease being studied (i.e., prodromal AD).
- 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 of harm to others.
- History of alcoholism or drug dependency/abuse within the last 5 years before Screening.
- Participant does not have a magnetic resonance imaging (MRI) scan obtained within 12 months of Screening and is unwilling or not eligible to undergo an MRI scan at the Screening Visit. With Sponsor approval, a head computed tomography (CT) scan may be substituted for MRI scan to evaluate eligibility.
- History of hepatitis or liver disease that has been active within the 6 months prior to Screening.
- Recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of Screening.
- History of malignancy occurring within the 5 years before Screening, 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 in the 6 months before Screening.
- Use of any investigational drugs or participation in clinical trials within the 30 days before Screening.
- History of a hypersensitivity reaction to more than three drugs.
- Has human immunodeficiency virus (HIV) by medical history.
- Participant is unwilling or has a contraindication to undergo PET scanning including but not limited to claustrophobia, excessive weight or girth.
- History or current evidence of long QT syndrome, corrected QT (QTc) interval ≥470 milliseconds (for male participants) or ≥480 milliseconds (for female participants), or torsades de pointes.
- Close family member (including the trial partner, spouse or children) who is among the personnel of the investigational or sponsor staff directly involved with this trial.