Trial Outcomes & Findings for The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients (NCT NCT00255086)

Results Overview

To determine if memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of hippocampal n-acetyl aspartate (NAA) and magnetic resonance imaging volumetric measures (MRI) of hippocampal volume.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

17 participants

Primary outcome timeframe

Baseline; Year 1

Results posted on

2017-04-07

Participant Flow

17 subjects were randomized. All subjects had completed all participation by October, 2008. All were recruited at VA Palo Alto Health Care System.

Participant milestones

Participant milestones
Measure	Memantine 10mg Memantine Memantine	Control Participants were given Placebo
Overall Study STARTED	9	8
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Memantine 10mg Memantine Memantine	Control Participants were given Placebo
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	1	1

Baseline Characteristics

The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantine n=7 Participants 10mg Memantine Memantine	Control n=6 Participants 10mg Placebo pill	Total n=13 Participants Total of all reporting groups
Age, Continuous	76.5 years n=5 Participants	75.4 years n=7 Participants	75.9 years n=5 Participants
Sex/Gender, Customized Female	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Sex/Gender, Customized Male	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Year 1

Population: Participants who could tolerate study medication and who completed the study were included in the analysis.

To determine if memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of hippocampal n-acetyl aspartate (NAA) and magnetic resonance imaging volumetric measures (MRI) of hippocampal volume.

Outcome measures

Outcome measures
Measure	Memantine n=4 Participants 10mg Memantine Memantine	Control n=6 Participants Participants were given Placebo
NAA/Cr Ratio Baseline	1.47 Ratio Standard Deviation 0.11	1.38 Ratio Standard Deviation 0.10
NAA/Cr Ratio Year 1	1.62 Ratio Standard Deviation 0.14	1.41 Ratio Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline; Year 1

Population: Participants who could tolerate study medication and who completed the study were included in the analysis.

Progression of cognitive functioning as measured by performance on the Alzheimer's Disease (AD) Assessment Scale-cognitive subscale (ADAS-Cog). ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics, and measures disturbances of of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Responses are summed for an overall score which can range from 0-70. The greater the dysfunction, the higher the score. A typical score for a person without dementia is 5.

Outcome measures

Outcome measures
Measure	Memantine n=4 Participants 10mg Memantine Memantine	Control n=6 Participants Participants were given Placebo
Mean Change on the ADAS-Cog Score After 1 Year Baseline	44.67 units on a scale Standard Deviation 10.30	49.17 units on a scale Standard Deviation 8.37
Mean Change on the ADAS-Cog Score After 1 Year 1 Year	45.75 units on a scale Standard Deviation 7.99	50.39 units on a scale Standard Deviation 8.88

Adverse Events

Memantine

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Control

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Memantine n=9 participants at risk 10mg Memantine	Control n=8 participants at risk Participants were given matching placebo
Cardiac disorders Cardiac Arrythmia	11.1% 1/9 • Number of events 1 • 1 month	0.00% 0/8 • 1 month
Gastrointestinal disorders Crohn's disease flare-ups	0.00% 0/9 • 1 month	12.5% 1/8 • Number of events 1 • 1 month
Endocrine disorders complications due to type II diabetes	0.00% 0/9 • 1 month	12.5% 1/8 • Number of events 1 • 1 month

Other adverse events

Other adverse events
Measure	Memantine n=9 participants at risk 10mg Memantine	Control n=8 participants at risk Participants were given matching placebo
Eye disorders Tattoo eyeliner	11.1% 1/9 • Number of events 1 • 1 month	0.00% 0/8 • 1 month
Psychiatric disorders Lethargy	11.1% 1/9 • Number of events 1 • 1 month	0.00% 0/8 • 1 month
Psychiatric disorders Irritability	22.2% 2/9 • Number of events 2 • 1 month	0.00% 0/8 • 1 month
Psychiatric disorders Study medication non compliance	33.3% 3/9 • Number of events 3 • 1 month	0.00% 0/8 • 1 month

Additional Information

Wes Ashford, PhD, MD

VA Palo Alto Health Care System

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place