- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04730635
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
February 8, 2023 updated by: Merck Sharp & Dohme LLC
A Clinical Study to Evaluate a Cognitive Platform to Support Development of Symptomatic Therapies in Participants at Risk for Alzheimer's Disease
The main purpose of this study is to assess the ability of a repeated high-frequency site-based computerized cognitive assessment to evaluate the potential treatment effects of donepezil (MK-0000) compared with placebo among participants with mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD).
The primary study hypothesis is that the average percentage of correct responses on one card learning (OCL) task will be ≥2 percentage points in participants receiving donepezil compared with participants receiving placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital-CALHN Memory Trials ( Site 0031)
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Health ( Site 0030)
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California
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Long Beach, California, United States, 90806
- Collaborative Neuroscience Network ( Site 0010)
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Florida
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Hallandale Beach, Florida, United States, 33009
- Velocity Clinical Research, Hallandale Beach ( Site 0013)
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Lady Lake, Florida, United States, 32159
- Charter Research - Lady Lake ( Site 0025)
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Georgia
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Decatur, Georgia, United States, 30030
- iResearch Atlanta ( Site 0005)
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Savannah, Georgia, United States, 31405
- iResearch Savannah ( Site 0023)
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center ( Site 0006)
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Ohio
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Beachwood, Ohio, United States, 44122
- Insight Clinical Trials ( Site 0020)
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Texas
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Fort Worth, Texas, United States, 76104
- North Texas Clinical Trials - Fort Worth - West Rosedale ( Site 0022)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has an Mini Mental State Examination (MMSE) score between 18 and 28 (inclusive) at Screening (Visit 1) and Baseline (Visit 2)
- Has a diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD)
- Has an Modified Hachinski Ischemia Scale (MHIS) score of ≤4
- Must have a reliable and competent study partner/informant who accompanies participant to study visits and participates in assessments
- Be willing to provide a blood sample for Apolipoprotein E (APOE) genotyping
- Does not have intellectual disability
- Be able to speak, read, hear, and understand the language of the study staff and the Informed Consent Form (ICF)
- Be able and willing to adhere to the study visit schedule
- Have visual acuity, visual function, hearing, and gross and fine motor skills adequate to support study participation
- Be capable of performing the Cogstate battery assessments, as demonstrated at the Baseline/Familiarization Visit (Visit 2)
- A female participant is eligible to participate if she is a woman of nonchildbearing potential (WONCBP)
Exclusion Criteria:
- Is at imminent risk of self-harm
- Has evidence of a clinically relevant neurological disorder other than AD at screening, including but not limited to: Parkinson's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, dementia with Lewy bodies, other types of dementia, neurosyphilis or that led to persistent cognitive deficits, or has a history of seizures or epilepsy within the last 5 years before screening
- Has a known history of stroke or has a diagnosis of vascular dementia
- Has history of multiple episodes of head trauma, or head trauma resulting in protracted loss of consciousness, or serious infectious disease affecting the brain, within the prior 3-5 years
- Has evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium
- Has a recent or ongoing, uncontrolled, clinically significant medical condition within 2 months of the Screening visit
- Has a history of cancer
- Has a relative contraindication to donepezil including sick sinus syndrome, first, second, or third-degree heart block, bradycardia, active gastrointestinal (GI) bleeding, Zollinger-Ellison syndrome, uncontrolled peptic ulcer disease, or uncontrolled asthma
- Has a history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. Exception: Participants with selected allergies may be enrolled with Sponsor's approval
- Is positive for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV) [participants with a history of chronic hepatitis C virus with a documented cure and/or a positive serologic test for HCV with a negative HCV viral load may be included]
- Has clinically significant vitamin B12 or folate deficiency in the 6 months immediately before screening, or vitamin B12 or folate deficiency in addition to increased serum homocysteine and methylmalonic acid levels at screening
- Has prior AD treatment
- Has participated in another investigational study within 4 weeks
- Has a known history of structural changes on screening magnetic resonance imaging (MRI) scan that are clinically important, including signs indicative of vascular dementia, large infarct, lacunes in critical areas, space-occupying lesions, or extensive white matter disease
- Is unwilling to or not eligible to undergo a MRI scan (if a prior MRI scan is not available)
- Is pregnant, is attempting to become pregnant, or is nursing children
- Has a history of alcoholism or drug dependency/abuse within the last 5 years prior to the Screening visit
- Consumes greater than 3 glasses of alcoholic beverages per day
- Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
- Is a regular user of cannabis, any illicit drugs or has a history of drug abuse within approximately 5 years. A participant who is a recreational user of cannabis or other drugs within the past 2 years can be enrolled as long as recreational use does not meet the definition of drug abuse and participant agrees to refrain from substance use for duration of study participation
- Participants must have a negative urine drug screen (UDS) prior to randomization
- Had major surgery within 3 months prior to the Screening visit that would interfere in the participant's ability to fully participate in the study
- Has undergone neuropsychological testing (including the MMSE) or cognitive remediation in the past 4 weeks
- Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Donepezil
Participants receive donepezil in doses up to 10 mg once daily (QD), orally in a scheduled titration for Days 1-56.
The total treatment duration is 56 days.
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Donepezil 5 mg capsules for a total daily dose of up to 10 mg QD, orally, for Days 1-56.
Other Names:
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PLACEBO_COMPARATOR: Placebo
Participants receive placebo QD, orally for Days 1-56.
The total treatment duration is 56 Days.
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Dose matched placebo capsule QD, orally for Days 1-56.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in Correct Responses on the One Card Learning (OCL) Task to Week 8
Time Frame: Baseline, Up to Week 8
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OCL uses a pattern separation paradigm to assess visual memory.
Tthe percentage change from baseline in correct responses on the OCL task up to Week 8 will be compared in participants receiving donepezil with participants receiving placebo.
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Baseline, Up to Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in the Overall Standard Deviation (sd) in Average OCL Task (Arcsine Square Root Transformed) to Week 8
Time Frame: Baseline, Up to Week 8
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OCL uses a pattern separation paradigm to assess visual memory.
The percentage change from baseline in correct responses on the OCL task up to Week 8 will be compared in participants receiving donepezil with participants receiving placebo.
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Baseline, Up to Week 8
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Percentage of Correct Responses on the OCL Task
Time Frame: Up to approximately Week 8
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OCL uses a pattern separation paradigm to assess visual memory.
The percentage of correct responses on the OCL task will be compared in participants receiving donepezil with participants receiving placebo up to approximately Week 8.
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Up to approximately Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 23, 2021
Primary Completion (ACTUAL)
January 20, 2023
Study Completion (ACTUAL)
February 6, 2023
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
January 26, 2021
First Posted (ACTUAL)
January 29, 2021
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- 0000-413
- MK-0000-413 (OTHER: Merck)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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