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Study of A Beta Secretase Inhibitor in Prodromal Alzheimer's Disease

Purpose

The Easton Center is currently participating in a Phase III clinical trial sponsored by Merck & Co of the investigational drug MK-8931. MK-8931 reduces levels of the beta amyloid protein by inhibiting the activity of an enzyme called beta secretase. MK-8931 is an oral medication taken daily. The study is approximately two years long, with roughly 12 study visits. Participants will be randomly assigned to the active study medication (MK-8931) or placebo. A placebo is a pill that looks just like the active medication but has no biological activity. Participants will have a 66% chance of receiving the active study medication. Individuals age 50-85 who have a memory problem are potentially eligible for this study. To learn more, please call Celine Ossinalde at (310) 794-6191 or send an email to: This email address is being protected from spambots. You need JavaScript enabled to view it..

Sponsor: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01953601

Condition: Intervention: Phase:
Amnestic Mild Cognitive Impairment
Alzheimer's Disease
Prodromal Alzheimer's Disease
Drug: MK-8931
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: 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
Eligibility
Ages Eligible for Study: 50 Years to 85 Years
Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

  1. Diagnosis of prodromal AD, including the following:
    1. History of subjective memory decline with gradual onset and slow progression for at least one year corroborated by an informant,
    2. Objective impairment in episodic memory by memory test performed at Screening,
    3. Does not meet criteria for dementia, AND
    4. Positive Screening amyloid imaging PET scan using [18F]flutametamol tracer or positive Screening CSF tau:amyloid-β42 (Aβ42) ratio.
  2. Able to read at a 6th grade level or equivalent.
  3. If participant is receiving an acetylcholinesterase inhibitor or memantine, the dose must have been stable for at least three months before Screening.
  4. 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:

  1. History of stroke.
  2. Evidence of a clinically relevant neurological disorder other than the disease being studied (i.e., prodromal AD).
  3. History of seizures or epilepsy within the last 5 years.
  4. Evidence of a clinically relevant or unstable psychiatric disorder, excluding major depression in remission.
  5. Participant is at imminent risk of self-harm or of harm to others.
  6. History of alcoholism or drug dependency/abuse within the last 5 years before Screening.
  7. 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.
  8. History of hepatitis or liver disease that has been active within the 6 months prior to Screening.
  9. Recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of Screening.
  10. 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.
  11. Clinically significant vitamin B12 or folate deficiency in the 6 months before Screening.
  12. Use of any investigational drugs or participation in clinical trials within the 30 days before Screening.
  13. History of a hypersensitivity reaction to more than three drugs.
  14. Has human immunodeficiency virus (HIV) by medical history.
  15. Participant is unwilling or has a contraindication to undergo PET scanning including but not limited to claustrophobia, excessive weight or girth.
  16. 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.
  17. 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.

Contact: Celine Ossinalde at (310) 794-6191 or This email address is being protected from spambots. You need JavaScript enabled to view it. to participate in this study or for more information.