Status:
COMPLETED
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Alzheimer's Disease
Mild Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
PHASE1
Brief Summary
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) com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04730635
Start Date
March 23 2021
End Date
February 6 2023
Last Update
October 28 2024
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Collaborative Neuroscience Network ( Site 0010)
Long Beach, California, United States, 90806
2
Velocity Clinical Research, Hallandale Beach ( Site 0013)
Hallandale, Florida, United States, 33009
3
Charter Research - Lady Lake ( Site 0025)
Lady Lake, Florida, United States, 32159
4
iResearch Atlanta ( Site 0005)
Decatur, Georgia, United States, 30030