Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
55–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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 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
Clareo Health | Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
