Trial Outcomes & Findings for Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease (NCT NCT03703856)
NCT ID: NCT03703856
Last Updated: 2026-01-07
Results Overview
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a tool used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. It includes 11 tasks that evaluate memory, language, and praxis. The total score can range from 0 to 70 with higher scores indicating more severe impairment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
0, 8, 16, 24 weeks
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Memantine
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
Memantine: Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 32 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this "challenge" test, a set of "early auditory information processing memantine sensitivity" measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated.
|
|---|---|
|
Enrolled in study
STARTED
|
53
|
|
Enrolled in study
COMPLETED
|
30
|
|
Enrolled in study
NOT COMPLETED
|
23
|
|
Titrated to full dose
STARTED
|
30
|
|
Titrated to full dose
COMPLETED
|
25
|
|
Titrated to full dose
NOT COMPLETED
|
5
|
|
8 week assessment
STARTED
|
25
|
|
8 week assessment
COMPLETED
|
25
|
|
8 week assessment
NOT COMPLETED
|
0
|
|
16 week assessment
STARTED
|
25
|
|
16 week assessment
COMPLETED
|
24
|
|
16 week assessment
NOT COMPLETED
|
1
|
|
24 week assessment
STARTED
|
24
|
|
24 week assessment
COMPLETED
|
23
|
|
24 week assessment
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Memantine
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
Memantine: Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 32 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this "challenge" test, a set of "early auditory information processing memantine sensitivity" measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated.
|
|---|---|
|
Enrolled in study
Withdrawal by Subject
|
23
|
|
Titrated to full dose
Withdrawal by Subject
|
5
|
|
16 week assessment
Withdrawal by Subject
|
1
|
|
24 week assessment
Withdrawal by Subject
|
1
|
Baseline Characteristics
Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Memantine
n=53 Participants
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
Memantine: Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 32 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this "challenge" test, a set of "early auditory information processing memantine sensitivity" measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated.
|
|---|---|
|
Age, Continuous
|
71.61 years
STANDARD_DEVIATION 6.89 • n=37 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 0, 8, 16, 24 weeksThe Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a tool used to assess the severity of cognitive impairment in individuals with Alzheimer's disease. It includes 11 tasks that evaluate memory, language, and praxis. The total score can range from 0 to 70 with higher scores indicating more severe impairment.
Outcome measures
| Measure |
Memantine
n=23 Participants
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
|
|---|---|
|
Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks
Week 24
|
20.79 scores on a scale
Standard Deviation 11.03
|
|
Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks
Baseline
|
19.76 scores on a scale
Standard Deviation 8.97
|
|
Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks
Week 8
|
19.81 scores on a scale
Standard Deviation 9.85
|
|
Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks
Week 16
|
19.94 scores on a scale
Standard Deviation 9.55
|
SECONDARY outcome
Timeframe: 0, 8, 16, 24 weeksThe NPI-Q measures behavioral symptoms in and is a self-administered questionnaire completed by informants about patients for whom they care. Each of the 12 NPI-Q domains contains a survey question that reflects cardinal symptoms of that domain. Symptoms are rated as present or absent, and if they are present the informant rates the severity of the symptom on a 3-point scale from mild to severe. The sum of severity scores across all 12 items ranges from 0 to 36 with higher scores indicate higher severity of symptoms.
Outcome measures
| Measure |
Memantine
n=53 Participants
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
|
|---|---|
|
Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks
Baseline
|
4.27 score on a scale
Standard Deviation 4.05
|
|
Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks
Week 8
|
3.55 score on a scale
Standard Deviation 3.36
|
|
Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks
Week 16
|
3.05 score on a scale
Standard Deviation 2.38
|
|
Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks
Week 24
|
4.09 score on a scale
Standard Deviation 3.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 8, 16, 24 weeksThe Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults using a "Yes/No" format. The GDS consists of 30 items with higher scores indicating greater levels or depression. A score of 0-9 is normal, 10-19 is mild depression, and 20-30 is severe depression.
Outcome measures
| Measure |
Memantine
n=53 Participants
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
|
|---|---|
|
Change From Baseline Measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 Weeks
Baseline
|
6.23 score on a scale
Standard Deviation 5.66
|
|
Change From Baseline Measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 Weeks
Week 8
|
6.05 score on a scale
Standard Deviation 5.92
|
|
Change From Baseline Measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 Weeks
Week 16
|
6.09 score on a scale
Standard Deviation 6.69
|
|
Change From Baseline Measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 Weeks
Week 24
|
6.64 score on a scale
Standard Deviation 6.89
|
Adverse Events
Memantine
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Memantine
n=53 participants at risk
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
|
|---|---|
|
Blood and lymphatic system disorders
Abnormal blood test presumed Chronic Lymphocytic Leukemia
|
1.9%
1/53 • From enrollment until end of last visit at 24 weeks
|
|
Reproductive system and breast disorders
Positive prostate biopsy
|
1.9%
1/53 • From enrollment until end of last visit at 24 weeks
|
Other adverse events
| Measure |
Memantine
n=53 participants at risk
EAIP are assessed 210 (PPI) and 345 min (MMN, ASSR) after administration of placebo or memantine (MEM 20 mg po), in a randomized order double-blind design. In this arm subjects are administered MEM 20 mg. Pills look identical so both the subject and research staff are blind to condition.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Swelling, forearm
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
General disorders
Unsteady gait
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
General disorders
Dizziness
|
5.7%
3/53 • Number of events 3 • From enrollment until end of last visit at 24 weeks
|
|
General disorders
Fatigue
|
7.5%
4/53 • Number of events 5 • From enrollment until end of last visit at 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • Number of events 4 • From enrollment until end of last visit at 24 weeks
|
|
General disorders
Weight loss
|
3.8%
2/53 • Number of events 3 • From enrollment until end of last visit at 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/53 • Number of events 2 • From enrollment until end of last visit at 24 weeks
|
|
Ear and labyrinth disorders
Tinnitis
|
3.8%
2/53 • Number of events 2 • From enrollment until end of last visit at 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
Ear and labyrinth disorders
Bump in left ear
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
Skin and subcutaneous tissue disorders
Facial rash
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Foot cramps
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
General disorders
Increased EtOH sensitivity
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
Nervous system disorders
Numbness in extremity
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
Infections and infestations
Positive COVID
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
|
Eye disorders
Visual changes in color perception
|
1.9%
1/53 • Number of events 1 • From enrollment until end of last visit at 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place