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TerminatedPhase 1Results posted

A Study to Evaluate the Effects of MK-0249 and an Alzheimer's Disease Medication on Cognitive Function in Adults With Alzheimer's Disease (MK-0249-023)

A Randomized Clinical Trial To Evaluate the Single Dose Acute Effects of MK-0249 and Donepezil On Cognitive Function In Adult Patients With Alzheimer's Disease

Assets

Donepezil / MK-0249

Listed sites

0

Recruiting sites

-

Enrollment

4

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•Study partner/caregiver required

Primary endpoint

•Time Weighted Average of the Change From Baseline After Single Dose

Identifiers

Registered as

Org study ID0249-023
Secondary2009_572
Secondary IDMK-0249-023Merck Sharp & Dohme Corp.
NCT IDNCT00874939

Timeline

Milestones

Study first posted2009-04-03estimated
Study start2009-04-06actual
Primary completion2009-04-20actual
Study completion2009-04-20actual
Results first posted2015-06-08estimated
Last update posted2018-10-17actual

Assets

Drug assets

DonepezilMK-0249

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Patient Specific:

•Female is not of reproductive potential
•Male who has a female partner(s) of child bearing potential, agrees to use acceptable method of contraception during the study
•Has at least 10 years of education or work history
•Has been a nonsmoker or has not used nicotine for at least 6 months
•Has a diagnosis of mild-to-moderate Alzheimer's Disease
•Has a reliable caregiver who consents to accompany the patient to all clinic visits, provide information to the study staff, and return for follow-up visits and procedures

Healthy Elderly Volunteer Specific:

•Is in good general health
•Has no clinically significant abnormality on electrocardiogram (ECG)

Exclusion criteria

Participant Specific:

•Has a history of a neurological disorder other than Alzheimer's disease
•Is living in a nursing home
•Has a history of stroke
•Has a history of psychotic disorder, an active major depressive disorder, or history of schizophrenia
•Has a history of a sleep disorder
•Has a history of a cardiovascular disorder
•Has a history of malignancy
•Is participating or has participated in a study with an investigational compound, device, or vaccine for Alzheimer's disease
•Consumes greater than 6 servings of caffeine (coffee, tea or cola etc.) per day
•Consumes greater than 3 alcoholic beverages per day
•Has had major surgery, donated or loss blood in past 8 weeks

Healthy Elderly Volunteer Specific:

•Is mentally or legally incapacitated, has significant emotional problems, or has a history of a psychiatric disorder over the last 5-10 years

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Executive function / language

8 endpoints
Primary/protocol endpoint

Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Primary/protocol endpoint

Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Primary/registry result

Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Primary/registry result

Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Secondary/protocol endpoint

Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Secondary/protocol endpoint

Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Secondary/registry result

Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Secondary/registry result

Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.

Time frame:Baseline and 5-7 hours post-dose

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.