Trial Outcomes & Findings for Treatment With Namenda in Women at Risk for Cognitive Decline (NCT NCT00242632)
NCT ID: NCT00242632
Last Updated: 2017-06-14
Results Overview
This tests verbal memory (word list). A list of words is presented and subjects are asked to recall as many as they can. Then a list of interference words is presented. Finally a recognition list of 44 words is presented where subjects are asked to distinguish between target words and distractors. The mean difference in the percentage of target words recalled between time 1 and time 2 is calculated below.
COMPLETED
NA
22 participants
6 months
2017-06-14
Participant Flow
Participant milestones
| Measure |
apoE-e4-
Subjects without the apoE-e4 allele
|
apoE-e4+
Subjects with the apoE-e4 allele
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment With Namenda in Women at Risk for Cognitive Decline
Baseline characteristics by cohort
| Measure |
apoE-e4-
n=11 Participants
Subjects without the apoE-e4 allele
|
apoE-e4+
n=11 Participants
Subjects with the apoE-e4 allele
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
57.73 years
STANDARD_DEVIATION 0 • n=99 Participants
|
59.09 years
STANDARD_DEVIATION 0 • n=107 Participants
|
58.41 years
STANDARD_DEVIATION 0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.
This tests verbal memory (word list). A list of words is presented and subjects are asked to recall as many as they can. Then a list of interference words is presented. Finally a recognition list of 44 words is presented where subjects are asked to distinguish between target words and distractors. The mean difference in the percentage of target words recalled between time 1 and time 2 is calculated below.
Outcome measures
| Measure |
T1-T2
n=22 Participants
This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
|
|---|---|
|
Change in California Verbal Learning Test - Second Edition Proactive Interference Test Between Time 1 and Time 2
|
20.41 percentage of target words recalled
Standard Deviation 5.63
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants were grouped together for this Outcome Measure. As per the protocol, the analyses of neuropsychological variables were to be done separately for the ApoE-ɛ4 carriers and non-carriers, only if the ApoE-ε4 status was a significant predictor of change in neuropsychological performance.
The Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. The mean difference in the total number of correct words generated between time 1 and time 2 is calculated below.
Outcome measures
| Measure |
T1-T2
n=22 Participants
This arm includes all 22 subjects from Time 1 to Time 2, a 6-month period.
|
|---|---|
|
Change in Delis-Kaplan Executive Function System (DKEFS) Verbal Fluency Category Switching Between Time 1 and Time 2
|
1.11 correct words
Standard Deviation 0.23
|
Adverse Events
ApoE-e4+
ApoE-e4-
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place