Trial Outcomes & Findings for Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for Alzheimer's Disease (NCT NCT00933608)
NCT ID: NCT00933608
Last Updated: 2014-10-21
Results Overview
The change in N-acetylaspartate (NAA) measured with magnetic resonance spectroscopy (MRS) is the primary outcome measure. NAA is a metabolite found predominately in neuronal cells, and its amount indicates tissue well being (the higher the better). In MRS studies NAA (and other metabolites like choline or myoinositol) are presented as a ratio to creatine (Cr) also measured by MRS. The concentration of creatine does not change is used as an internal standard. The ratio NAA/Cr is unitless. In summary, the measurable outcome will be the NAA/Cr ratio change from pre-to post treatment.
COMPLETED
PHASE4
17 participants
baseline (pre-treatment) and 4 months (post-treatment)
2014-10-21
Participant Flow
Recruitment for this study was carried out at the NYU Center for Brain Health and Aging and Dementia Center, between May 2010 and October 2011.
Participant milestones
| Measure |
Memantine
memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
|
Placebo
participants were taking 1 tablet twice a day to match memantine arm
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
2
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Memantine
memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
|
Placebo
participants were taking 1 tablet twice a day to match memantine arm
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Memantine
n=7 Participants
memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
|
Placebo
n=10 Participants
|
Total
n=17 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
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
69.7 years
STANDARD_DEVIATION 8.2 • n=107 Participants
|
69.7 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
10 participants
n=107 Participants
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline (pre-treatment) and 4 months (post-treatment)Population: This is an intention to treat analysis, based on initial treatment assignment.
The change in N-acetylaspartate (NAA) measured with magnetic resonance spectroscopy (MRS) is the primary outcome measure. NAA is a metabolite found predominately in neuronal cells, and its amount indicates tissue well being (the higher the better). In MRS studies NAA (and other metabolites like choline or myoinositol) are presented as a ratio to creatine (Cr) also measured by MRS. The concentration of creatine does not change is used as an internal standard. The ratio NAA/Cr is unitless. In summary, the measurable outcome will be the NAA/Cr ratio change from pre-to post treatment.
Outcome measures
| Measure |
Memantine
n=4 Participants
memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
|
Placebo
n=9 Participants
participant will be taking 1 tablet twice a day to match active arm
|
|---|---|---|
|
N-acetylaspartate
pre-treatment
|
1.35 NAA/creatine Ratio
Standard Deviation .38
|
1.86 NAA/creatine Ratio
Standard Deviation .43
|
|
N-acetylaspartate
post-treatment
|
1.58 NAA/creatine Ratio
Standard Deviation .005
|
1.26 NAA/creatine Ratio
Standard Deviation .49
|
Adverse Events
Memantine
Placebo
Serious adverse events
| Measure |
Memantine
n=7 participants at risk
memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
|
Placebo
n=10 participants at risk
|
|---|---|---|
|
General disorders
loss of consciousness
|
14.3%
1/7
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
severe anemia
|
0.00%
0/7
|
10.0%
1/10
|
Other adverse events
| Measure |
Memantine
n=7 participants at risk
memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
|
Placebo
n=10 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin rash
|
14.3%
1/7
|
0.00%
0/10
|
|
Ear and labyrinth disorders
dizziness
|
14.3%
1/7
|
0.00%
0/10
|
|
Vascular disorders
high blood presure
|
14.3%
1/7
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place