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Trial Outcomes & Findings for Magnetic Resonance Spectroscopy Study of Memantine in Alzheimer's Disease (NCT NCT00551161)

NCT ID: NCT00551161

Last Updated: 2014-01-28

Results Overview

Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 \[(t2 - t1) - (t1 - t0)\].

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 24 weeks, and 48 weeks

Results posted on

2014-01-28

Participant Flow

August, 2007 through May, 2010, at the Litwin-Zucker Research Center

Participant milestones

Participant milestones
Measure
Memantine
24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
Overall Study
STARTED
12
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Memantine
24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Magnetic Resonance Spectroscopy Study of Memantine in Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Single-arm
n=12 Participants
24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
12 Participants
n=5 Participants
Age, Continuous
76.1 years
STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 24 weeks, and 48 weeks

Population: Per protocol

Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 \[(t2 - t1) - (t1 - t0)\].

Outcome measures

Outcome measures
Measure
Memantine
n=11 Participants
24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in NAA [(t2-t1) - (t1-t0)]
-54 ratio (normalized to T2-corrected water
Standard Deviation 102
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in Cr [(t2-t1) - (t1-t0)]
-2 ratio (normalized to T2-corrected water
Standard Deviation 36
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in Cho [(t2-t1) - (t1-t0)]
9 ratio (normalized to T2-corrected water
Standard Deviation 12
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in mI [(t2-t1) - (t1-t0)]
16 ratio (normalized to T2-corrected water
Standard Deviation 23
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in NAA/Cr [(t2-t1) - (t1-t0)]
-0.09 ratio (normalized to T2-corrected water
Standard Deviation 0.15
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in Cho/Cr [(t2-t1) - (t1-t0)]
0.02 ratio (normalized to T2-corrected water
Standard Deviation 0.06
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in mI/Cr [(t2-t1) - (t1-t0)]
0.04 ratio (normalized to T2-corrected water
Standard Deviation 0.08
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in NAA/Cho [(t2-t1) - (t1-t0)]
-0.26 ratio (normalized to T2-corrected water
Standard Deviation 0.39
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Change in NAA/mI [(t2-t1) - (t1-t0)]
-0.35 ratio (normalized to T2-corrected water
Standard Deviation 0.50

Adverse Events

Single-arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc L. Gordon,MD

North Shore-LIJ Health System

Phone: 516-562-3492

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place