Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04730635) enrolled 44 people in total — 29 in the donepezil (medication) group and 15 in the placebo (dummy treatment) group. Most participants finished the study: 28 in the donepezil group and 14 in the placebo group completed it, with one person dropping out from each group. The trial was looking at whether donepezil had any effect on a specific type of visual memory test called the One Card Learning task, which asks participants to recognise patterns and is used to assess memory, in people with mild cognitive impairment or mild Alzheimer's disease. The main thing being measured was how much each participant's score on that memory test changed over 8 weeks. The reported data shows that, on the primary (main) outcome, participants in the donepezil group had an average improvement in their correct response rate of 0.055 (out of a possible proportion of 1.0), while participants in the placebo group had an average improvement of 0.034. For the secondary (additional) outcomes, which looked at the variability — that is, how much individual scores spread around the average — the reported figures were similar between the two groups and were presented using a mathematical transformation, making them harder to interpret directly in everyday terms. No figures were reported for the placebo group on the final secondary outcome, as that analysis only included the donepezil group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Alzheimer's Disease Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You scored between 18 and 28 on a standard memory and thinking test (called the MMSE) at two separate early visits
- You have been diagnosed with either mild cognitive impairment (MCI) or mild Alzheimer's Disease
- You scored 4 or below on a scale that helps rule out memory problems caused by reduced blood flow to the brain (confirm with trial site)
- You have a trusted person (such as a family member or close friend) who can come to study visits with you and take part in some assessments
- You are willing to give a blood sample to check for a gene linked to Alzheimer's risk (called APOE)
- You do not have an intellectual disability
- You can speak, read, hear, and understand the language used by the study team and in the consent forms
- You are able and willing to attend all required study visits
- You have adequate vision, hearing, and hand and body movement skills to take part in the study
- You are able to complete a set of computer-based thinking and memory tests, as shown at an early study visit
- If you are female, you are not able to become pregnant (confirm with trial site)
Who may not be able to join:
- You are at immediate risk of harming yourself
- You have a neurological condition other than Alzheimer's (such as Parkinson's disease, Huntington's disease, multiple sclerosis, or epilepsy/seizures in the past 5 years), or any condition that has caused lasting thinking or memory problems
- You have had a stroke or have been diagnosed with dementia caused by problems with blood flow in the brain
- You have had multiple head injuries, a head injury with a long period of unconsciousness, or a serious brain infection in the past 3 to 5 years
- You have an active and significant mental health condition such as schizophrenia, bipolar disorder, major depression, or delirium
- You have had an uncontrolled, significant health condition within the 2 months before your screening visit
- You have a history of cancer
- You have certain heart, stomach, or breathing conditions that make taking the study drug (donepezil) unsafe (confirm with trial site for the specific conditions)
- You have a history of severe allergies or serious reactions to medications or foods (some exceptions may be possible with approval)
- You have tested positive for Hepatitis B, Hepatitis C (unless fully cured with documented evidence), or HIV
- You have had a significant deficiency in vitamin B12 or folate in the 6 months before screening, or have related abnormal blood test results at screening
- You have previously received treatment specifically for Alzheimer's Disease
- You have taken part in another clinical study within the past 4 weeks
- A previous MRI brain scan showed important structural changes, such as signs of stroke, large damaged areas, tumours, or extensive damage to brain tissue
- You are unwilling or unable to have an MRI scan, and no recent MRI scan is already available
- You are pregnant, trying to become pregnant, or currently breastfeeding
- You have had problems with alcohol or drug dependency or abuse in the past 5 years
- You drink more than 3 alcoholic drinks per day
- You consume more than 6 caffeinated drinks (such as coffee, tea, cola, or energy drinks) per day
- You regularly use cannabis or illegal drugs, or have a history of drug abuse in the past 5 years (occasional recreational use in the past 2 years may be considered if it does not meet the definition of abuse and you agree to stop during the study — confirm with trial site)
- You test positive on a urine drug screening test before being enrolled in the study
- You had major surgery within 3 months before the screening visit that would affect your ability to fully take part
- You have had memory or thinking tests (including the MMSE) or cognitive training in the past 4 weeks
- You or a close family member works at the study site or for the company running this trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Medical Director, Merck Sharp & Dohme LLC
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in Averaged Correct Response Rate on the One Card Learning Task to Week 8
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.