Phase
Condition
Memory Loss
Alzheimer's Disease
Dementia
Treatment
Donepezil
Placebo
MK-1167
Clinical Study ID
Ages 50-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Reports a history of cognitive and functional decline with gradual onset and slowprogression for at least 1 year before Screening, that is either corroborated by aninformant who knows the subject well or is documented in medical records
Meets the criteria for a diagnosis of probable Alzheimer's disease (AD) based on theNational Institute of Neurological and Communicative Disorders - Stroke and theAlzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria forprobable AD
Is receiving donepezil 10 mg daily for symptomatic treatment of cognitive impairmentassociated with AD. The dose level must be stable for at least 2 months prior toScreening. If receiving donepezil via a transdermal system (ie, patch), it should bea 10-mg/day dose and should switch prescription to a 10-mg oral daily dose, beforeenrollment
Has a reliable and competent trial partner/caregiver who has a close relationshipwith the participant, has face-to-face contact at least 3 days a week for a minimumof 6 waking hours a week, and is willing to accompany the participant, if desired,to study visits
Exclusion
Exclusion Criteria:
History of clinically significant endocrine, gastrointestinal, cardiovascular,hematological, hepatic, immunological, renal, respiratory, genitourinary, or majorneurological (including stroke and chronic seizures) abnormalities or diseases thatare not under medical control over the past 2 months.
Has evidence of a clinically relevant or unstable psychiatric disorder, based onDSM-5 criteria, or has a history of clinically significant psychiatric disorder inthe last 5 years. Generalized anxiety disorder, and/or insomnia under good controlfor ≥ 2 months on stable medical therapy may not be exclusionary.
History of cancer (malignancy). Participants with adequately treated disease deemedas "cured," or who, in the opinion of the study investigator, are highly unlikely tosustain a recurrence for the duration of the study, may be enrolled at thediscretion of the investigator and Sponsor.
History of significant multiple and/or severe allergies (eg, food, drug, latexallergy), or has had an anaphylactic reaction or significant intolerability (ie,systemic allergic reaction) to prescription or nonprescription drugs or food.
Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL)within 4 weeks prior to the prestudy (screening) visit.
Unable to refrain from or anticipates the use of any medication, includingprescription and nonprescription drugs or herbal remedies beginning approximately 2weeks (or 5 half-lives) prior to administration of the initial dose of studyintervention, throughout the study, until the poststudy visit. There may be certainprotocol-specified medications that are permitted.
The participant is a smoker and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening.
Consumes greater than 3 servings of alcoholic beverages per day. Participants whoconsume 4 servings of alcoholic beverages per day may be enrolled at the discretionof the investigator.
The participant is a regular user of cannabis, any illicit drugs or has a history ofdrug (including alcohol) abuse within approximately 2 years.
Study Design
Connect with a study center
Velocity Clinical Research, Hallandale Beach ( Site 0001)
Hallandale Beach, Florida 33009
United StatesSite Not Available
CenExel iResearch, LLC ( Site 0003)
Decatur, Georgia 30030
United StatesSite Not Available
CenExel iResearch, LLC ( Site 0004)
Savannah, Georgia 31405
United StatesSite Not Available
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