Trial Outcomes & Findings for 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) (NCT NCT00874939)
NCT ID: NCT00874939
Last Updated: 2018-10-17
Results Overview
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.
TERMINATED
PHASE1
4 participants
Baseline and 5-7 hours post-dose
2018-10-17
Participant Flow
Eight participants were screened and four were enrolled in the study.
The study was terminated prior to randomization and treatment.
Participant milestones
| Measure |
All Participants
All enrolled participants
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
Treated
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Participants
All enrolled participants
|
|---|---|
|
Overall Study
Study terminated
|
4
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
All Participants
n=4 Participants
All enrolled participants
|
|---|---|
|
Age, Continuous
|
67 Years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 5-7 hours post-dosePopulation: Analysis was not performed due to termination of the study prior to randomization and treatment.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 5-7 hours post-dosePopulation: Analysis was not performed due to termination of the study prior to randomization and treatment.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 5-7 hours post-dosePopulation: Analysis was not performed due to termination of the study prior to randomization and treatment.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 5-7 hours post-dosePopulation: Analysis was not performed due to termination of the study prior to randomization and treatment.
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.
Outcome measures
Outcome data not reported
Adverse Events
MK-0249 7.5 mg
Donepezil 5 mg
MK-0249 25 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER