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NCT04308304 | Completed | Alzheimer's Disease


MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)
Sponsor:

Merck Sharp & Dohme LLC

Brief Summary:

The study will investigate the effects on safety and pharmacokinetics (PK) of MK-1942 and donepezil when co-administered to participants with Alzheimer's Disease with mild-to-moderate cognitive impairment stably treated with donepezil. The objectives of this study include determining if the combination of MK-1942 with donepezil increases the incidence or severity of adverse events (AEs) previously reported for these agents, or results in unanticipated AEs in the patient population targeted for MK-1942 treatment. In addition, any changes in the PK parameters of either MK-1942 or donepezil as a result of co-administration will be assessed.

Condition or disease

Alzheimer's Disease

Intervention/treatment

MK-1942

Donepezil

Placebo

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 27 participants
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Pharmacokinetics of MK-1942 Administered to Alzheimer's Disease Patients Receiving Donepezil Treatment.
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : May 18, 2022
Estimated Study Completion Date : May 18, 2022
Arm Intervention/treatment

Experimental: MK-1942

Dose Level 1: 8-mg MK-1942 twice daily (BID) x 7 days (7D), Day 1 to Day 7; Dose Level 2: 15-mg MK-1942 BID x 7D, Day 8 to Day 14; Dose Level 3: 30-mg MK-1942 BID x 7D, Day 15 to Day 21; Dose Level 4: ≤50-mg MK-1942 BID x 7D (Provisional Dose Level), Day 22 to Day 28 All participants to receive Donepezil once daily.

Drug: MK-1942

Drug: Donepezil

Placebo Comparator: Placebo

Placebo to MK-1942 BID x 21 [28] D All participants to receive Donepezil once daily.

Drug: Donepezil

Drug: Placebo

Ages Eligible for Study: 50 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Body mass index (BMI) ≥18 and ≤35 kg/m^2, inclusive.
  • Is in good health based on medical history, physical examination, vital sign measures and electrocardiogram performed prior to randomization.
  • Have a negative urine drug screen prior to randomization.
  • Have a history of cognitive and functional decline with gradual onset and slow progression for at least one year before screening that is either corroborated or well-documented.
  • Be receiving donepezil (maximum dose: ≥10-mg, ≤15-mg) for symptomatic treatment of cognitive impairment associated with Alzheimer's dementia. The dose level must be stable for at least 1 month prior to screening.
  • Have a reliable and competent trial partner/caregiver who has a close relationship with the subject, has face-to-face contact at least three days a week for a minimum of six waking hours a week, and is willing to accompany the participant, if desired, to trial visits. The trial partner/caregiver should understand the nature of the trial and adhere to trial requirements (e.g., dosing, visit schedules, and nature and number of evaluations).
  • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male participants must refrain from donating sperm PLUS agree to study guidelines regarding abstinent and/or contraception during the intervention period and for at least an additional 90 days (a spermatogenesis cycle) after the last dose of study intervention:
  • A female participant is eligible to participate if she is a women of nonchildbearing potential by study criteria.
Exclusion Criteria
  • Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
  • Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (CSSRS), or of harm to others in the opinion of the investigator.
  • Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
  • Has a history of uncontrolled, clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • Candidates should not have a history of asthma, chronic obstructive pulmonary disease, urinary obstructions or gastrointestinal bleeding.
  • Has a history of cancer (malignancy) exceptions for (1) Adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or; (2) Other malignancies which have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study.
  • Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or non-prescription drugs or food.
  • Has evidence of a clinically relevant or unstable psychiatric disorder, based on The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, bipolar disorder, or delirium at the time of the pre-study (screening) visit, or has a history of clinically significant psychiatric disorder of the last 5 years.
  • Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the pre-study (screening) visit.

MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)

Location Details


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MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005)

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Arkansas

Woodland Research Northwest, LLC ( Site 0004)

Rogers, Arkansas, United States, 72758-6442

Not yet recruiting

United States, Florida

Velocity Clinical Research, Hallandale Beach ( Site 0002)

Hallandale Beach, Florida, United States, 33009

Not yet recruiting

United States, Georgia

iResearch Atlanta ( Site 0005)

Decatur, Georgia, United States, 30030

Not yet recruiting

United States, Utah

ICON ( Site 0003)

Salt Lake City, Utah, United States, 84124

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