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Efficacy and Safety Trial of Verubecestat (MK-8931) in Participants With Prodromal Alzheimer's Disease (MK-8931-019) | Clinical Trials | Clareo Health

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

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)

NCT01953601•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study consists of two parts, Part 1 and Part 2. Part 1 assesses the efficacy and safety of verubecestat (MK-8931) compared with placebo administered for 104 weeks in the treatment of amnestic mild cognitive impairment (aMCI) due to Alzheimer's Disease (AD), also known as prodromal AD. Participants are randomized to receive placebo, or 12 mg or 40 mg verubecestat, once daily. The primary study hypothesis for Part 1 is that ≥1 verubecestat 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. Participants completing Part 1 may choose to participate in Part 2, which is a long term double-blind extension to assess efficacy and safety of verubecestat administered for up to an additional 260 weeks. In Part 2, all participants receive either 12 mg or 40 mg verubecestat, once daily.

Detailed Description

As a result of protocol amendment, Study Part 2 will contain a Positron Emission Tomography (PET) imaging substudy to assess regional neurofibrillary tangle (NFT) expression.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

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 (Participants with a prior positive amyloid imaging PET scan or a Screening PET scan with florbetaben or florbetapir may be enrolled without a Screening flutemetamol scan with Sponsor approval)
•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
•1. Tolerated study drug and completed the initial 104-week period of the trial (Part 1)
•2. Participant must have a reliable and competent trial partner who must have a close relationship with the subject

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
•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 more criteria

Key Dates

Start Date

November 5, 2013

Primary Completion Date

April 17, 2018

Completion Date

April 17, 2018

Last Updated

May 17, 2019

Enrollment

1,454

ACTUAL participants

Conditions

Amnestic Mild Cognitive ImpairmentAlzheimer's DiseaseProdromal Alzheimer's Disease

Interventions

Verubecestat 12 mg (Parts 1 and 2)

DRUG

Verubecestat 40 mg (Parts 1 and 2)

DRUG

Placebo (Part 1)

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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