Efficacy and Safety Trial of MK-8931 in Participants With Prodromal Alzheimer's Disease (MK-8931-019)

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 13-006525
    NCT ID: NCT01953601
    Sponsor Protocol Number: 019-05

About this study

The purpose of this trial is to assess the efficacy and safety of MK-8931 compared with placebo in the treatment of amnestic mild cognitive impairment (aMCI) due to Alzheimer's Disease (AD), also known as prodromal AD. Participants will be randomized to receive placebo, or 12 mg or 40 mg MK-8931, once daily. The primary study hypothesis is that at least one MK-8931 dose is superior to placebo with respect to the change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at 104 weeks.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Richard Caselli, M.D.

Closed for enrollment

Contact information:

Teresa Radam CCRP

(480)342-3775

radam.teresa@mayo.edu