Alzheimer's DiseasePhase 1NCT00874939

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 Phase 1 study testing MK-0249 7.5 mg, MK-0249 25 mg and Donepezil 5mg in people with Alzheimer's Disease and Dementia, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer's Disease, Dementia
What is being tested?: MK-0249 7.5 mg, MK-0249 25 mg and Donepezil 5mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: No sites listed yet
Study dates: 6 Apr 2009to 20 Apr 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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

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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)

Who cannot join

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

Show all 14Show fewer

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

About this study

Official title: 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

This study will evaluate acute symptomatic improvements in cognitive performance in healthy elderly participants with mild-to-moderate Alzheimer's disease. A four-week pilot study will first evaluate the CogState computerized cognitive battery in participants who are not receiving treatment. After completion of the pilot study, participants will be randomized to receive Placebo, Donepezil 5 mg, MK-0249 7.5 mg, and MK-0249 25 mg. After each drug administration the participants will be given the CogState computerized cognitive battery to assess cognitive performance. The primary hypotheses are that cognitive performance in participants with Alzheimer's disease, or in healthy participants, is improved by the administration of a single oral 5 mg dose of Donepezil as compared to placebo.

Conditions: Alzheimer's Disease, Dementia
Being tested: MK-0249 7.5 mg, MK-0249 25 mg, Donepezil 5mg, Placebo to MK-0249, Placebo to Donepezil
Medical subject headings: Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-0249 7.5 mgDrug
4 tablets (1 x 0.5 mg + 2 x 1 mg + 1 x 5 mg) totaling 7.5 mg, single oral dose during each crossover period
MK-0249 25 mgDrug
5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period
Donepezil 5mgDrug
Also called Aricept
One 5 mg tablet, single oral dose during each crossover period
Placebo to MK-0249Drug
Five tablets, single oral dose during each crossover period
Placebo to DonepezilDrug
One over-encapsulated capsule, single oral dose during each crossover period

Study groups in NCT00874939
Study group	Role	What they receive
PBO→MK-7.5→DON→MK-25	Experimental	Treatment by single oral dose with Placebo (PBO) in the first crossover period; MK-0249 7.5 mg (MK-7.5) in the second crossover period; Donepezil 5 mg (DON) in the third crossover period; and MK-0249 25 mg (MK-25) in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
MK-7.5→PBO→MK-25→DON	Experimental	Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 25 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
DON→MK-25→PBO→MK-7.5	Experimental	Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
MK-25→DON→MK-7.5→PBO	Experimental	Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Placebo in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
PBO→MK-25→MK-7.5→DON	Experimental	Treatment by single oral dose with Placebo in the first crossover period; MK-0249 25 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
MK-7.5→DON→PBO→MK-25	Experimental	Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Donepezil 5 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 25 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
DON→MK-7.5→MK-25→PBO	Experimental	Treatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and Placebo in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
MK-25→PBO→DON→MK-7.5	Experimental	Treatment by single oral dose with MK-0249 25 mg in the first crossover period; Placebo in the second crossover period; Donepezil 5 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
PBO→DON→MK-25→MK-7.5	Experimental	Treatment by single oral dose with Placebo in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
MK-7.5→MK-25→DON→PBO	Experimental	Treatment by single oral dose with MK-0249 7.5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Donepezil 5 mg in the third crossover period; and Placebo in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
DON→PBO→MK-7.5→MK-25	Experimental	Treatment by single oral dose with Donepezil 5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 7.5 mg in the third crossover period; and MK-0249 25 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil
MK-25→MK-7.5→PBO→DON	Experimental	Treatment by single oral dose with MK-0249 25 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; Placebo in the third crossover period; and Donepezil 5 mg in the fourth crossover period. Receives: Drug: MK-0249 7.5 mg; Drug: MK-0249 25 mg; Drug: Donepezil 5mg; Drug: Placebo to MK-0249; Drug: Placebo to Donepezil

What is being measured

The primary outcome is the main question the study is designed to answer.

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
The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
Measured: Baseline and 5-7 hours post-dose
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
The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
Measured: Baseline and 5-7 hours post-dose

Secondary outcomes (2)

Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.
The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
Measured: Baseline and 5-7 hours post-dose
Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.
The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
Measured: Baseline and 5-7 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 200920 Apr 2009

First posted3 Apr 2009 (estimated)
Study start6 Apr 2009
Primary completion20 Apr 2009
Study completion20 Apr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00874939
Sponsor's protocol ID: 0249-023
Other IDs: MK-0249-023, 2009_572
Status last verified: Sep 2018
First submitted: 2 Apr 2009
Last updated: 17 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00874939
Acronym / sponsor ID: 0249-023
Conditions: Alzheimer's Disease, Dementia
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 4 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Apr 2009 (actual)
Primary completion: 20 Apr 2009 (actual)
Study completion: 20 Apr 2009 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Posted 8 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 12

Arm	Type	Receives
PBO→MK-7.5→DON→MK-25	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with Placebo (PBO) in the first crossover period; MK-0249 7.5 mg (MK-7.5) in the second crossover period; Donepezil 5 mg (DON) in the third crossover period; and MK-0249 25 mg (MK-25) in the fourth crossover period.
MK-7.5→PBO→MK-25→DON	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 25 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period.
DON→MK-25→PBO→MK-7.5	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.
MK-25→DON→MK-7.5→PBO	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with MK-0249 25 mg in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Placebo in the fourth crossover period.
PBO→MK-25→MK-7.5→DON	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with Placebo in the first crossover period; MK-0249 25 mg in the second crossover period; MK-0249 7.5 mg in the third crossover period; and Donepezil 5 mg in the fourth crossover period.
MK-7.5→DON→PBO→MK-25	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with MK-0249 7.5 mg in the first crossover period; Donepezil 5 mg in the second crossover period; Placebo in the third crossover period; and MK-0249 25 mg in the fourth crossover period.
DON→MK-7.5→MK-25→PBO	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with Donepezil 5 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and Placebo in the fourth crossover period.
MK-25→PBO→DON→MK-7.5	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with MK-0249 25 mg in the first crossover period; Placebo in the second crossover period; Donepezil 5 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.
PBO→DON→MK-25→MK-7.5	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with Placebo in the first crossover period; Donepezil 5 mg in the second crossover period; MK-0249 25 mg in the third crossover period; and MK-0249 7.5 mg in the fourth crossover period.
MK-7.5→MK-25→DON→PBO	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with MK-0249 7.5 mg in the first crossover period; MK-0249 25 mg in the second crossover period; Donepezil 5 mg in the third crossover period; and Placebo in the fourth crossover period.
DON→PBO→MK-7.5→MK-25	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with Donepezil 5 mg in the first crossover period; Placebo in the second crossover period; MK-0249 7.5 mg in the third crossover period; and MK-0249 25 mg in the fourth crossover period.
MK-25→MK-7.5→PBO→DON	Experimental	Drug: MK-0249 7.5 mg, Drug: MK-0249 25 mg, Drug: Donepezil 5mg, Drug: Placebo to MK-0249, Drug: Placebo to DonepezilTreatment by single oral dose with MK-0249 25 mg in the first crossover period; MK-0249 7.5 mg in the second crossover period; Placebo in the third crossover period; and Donepezil 5 mg in the fourth crossover period.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-0249 7.5 mg4 tablets (1 x 0.5 mg + 2 x 1 mg + 1 x 5 mg) totaling 7.5 mg, single oral dose during each crossover period	Drug	DON→MK-25→PBO→MK-7.5, DON→MK-7.5→MK-25→PBO, DON→PBO→MK-7.5→MK-25, MK-25→DON→MK-7.5→PBO, MK-25→MK-7.5→PBO→DON, MK-25→PBO→DON→MK-7.5, MK-7.5→DON→PBO→MK-25, MK-7.5→MK-25→DON→PBO, MK-7.5→PBO→MK-25→DON, PBO→DON→MK-25→MK-7.5, PBO→MK-25→MK-7.5→DON, PBO→MK-7.5→DON→MK-25
MK-0249 25 mg5 x 5 mg tablets totaling 25 mg, single oral dose during each crossover period	Drug	DON→MK-25→PBO→MK-7.5, DON→MK-7.5→MK-25→PBO, DON→PBO→MK-7.5→MK-25, MK-25→DON→MK-7.5→PBO, MK-25→MK-7.5→PBO→DON, MK-25→PBO→DON→MK-7.5, MK-7.5→DON→PBO→MK-25, MK-7.5→MK-25→DON→PBO, MK-7.5→PBO→MK-25→DON, PBO→DON→MK-25→MK-7.5, PBO→MK-25→MK-7.5→DON, PBO→MK-7.5→DON→MK-25
Donepezil 5mgAlso: AriceptOne 5 mg tablet, single oral dose during each crossover period	Drug	DON→MK-25→PBO→MK-7.5, DON→MK-7.5→MK-25→PBO, DON→PBO→MK-7.5→MK-25, MK-25→DON→MK-7.5→PBO, MK-25→MK-7.5→PBO→DON, MK-25→PBO→DON→MK-7.5, MK-7.5→DON→PBO→MK-25, MK-7.5→MK-25→DON→PBO, MK-7.5→PBO→MK-25→DON, PBO→DON→MK-25→MK-7.5, PBO→MK-25→MK-7.5→DON, PBO→MK-7.5→DON→MK-25
Placebo to MK-0249Five tablets, single oral dose during each crossover period	Drug	DON→MK-25→PBO→MK-7.5, DON→MK-7.5→MK-25→PBO, DON→PBO→MK-7.5→MK-25, MK-25→DON→MK-7.5→PBO, MK-25→MK-7.5→PBO→DON, MK-25→PBO→DON→MK-7.5, MK-7.5→DON→PBO→MK-25, MK-7.5→MK-25→DON→PBO, MK-7.5→PBO→MK-25→DON, PBO→DON→MK-25→MK-7.5, PBO→MK-25→MK-7.5→DON, PBO→MK-7.5→DON→MK-25
Placebo to DonepezilOne over-encapsulated capsule, single oral dose during each crossover period	Drug	DON→MK-25→PBO→MK-7.5, DON→MK-7.5→MK-25→PBO, DON→PBO→MK-7.5→MK-25, MK-25→DON→MK-7.5→PBO, MK-25→MK-7.5→PBO→DON, MK-25→PBO→DON→MK-7.5, MK-7.5→DON→PBO→MK-25, MK-7.5→MK-25→DON→PBO, MK-7.5→PBO→MK-25→DON, PBO→DON→MK-25→MK-7.5, PBO→MK-25→MK-7.5→DON, PBO→MK-7.5→DON→MK-25

Primary outcome

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
The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.
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
The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 8 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	4	0

Primary outcome: 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

Population analysed: Analysis was not performed due to termination of the study prior to randomization and treatment.

Primary outcome: 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

Population analysed: Analysis was not performed due to termination of the study prior to randomization and treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 21 days after last dose of study drug (approximately 67 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0249 7.5 mg	0 of 0	0 of 0	Not reported
Donepezil 5 mg	0 of 0	0 of 0	Not reported
MK-0249 25 mg	0 of 0	0 of 0	Not reported
Placebo	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-0249 7.5 mg, MK-0249 25 mg and Donepezil 5mg in people with Alzheimer's Disease and Dementia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00874939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.