MemAP

TerminatedPhase 4Results posted

Memantine and Antipsychotics Use

Prospective, Single-arm, Multi-centre, Open-label Study to Investigate the Potential to Reduce Concomitant Antipsychotics Use in Patients With Moderate to Severe Dementia of Alzheimer's Type (DAT) Treated With Memantine

Lead sponsor

Merz Pharmaceuticals GmbH

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2007-004489-41

Org study IDMRZ 90001-0716/1

NCT IDNCT00649220

Timeline

Milestones

Study first posted2008-04-01estimated

Study start2008-07 (month precision)

Primary completion2009-05actual (month precision)

Study completion2009-06actual (month precision)

Results first posted2011-09-13estimated

Last update posted2011-09-26estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.

•MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders.

•Patients treated with any acetylcholinesterase inhibitor (AChEI) man be included.

•The patient should have German as a mother-tongue or at least speak the language fluently

Exclusion criteria

•Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.

•Modified Hachinski Ischemia score greater than 4 at screening.

•Intake of any medication that is contra-indicated in combination with memantine.

•Treatment with depot antipsychotics.

•History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine or lactose.

•Known or suspected history of alcoholism or drug abuse within the past 10 years.

•Previous treatment with memantine or participation in an investigational study with memantine.

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

Function / daily living

Global cognition

2 endpoints

Secondary/protocol endpoint

Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.

Time frame:Week 20 post baseline

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change in the Mini-Mental State Examination (MMSE) Score Value From Baseline to Week 20.

Time frame:Week 20 post baseline

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Reported spread / bounds
Memantinen=15 Participants	0.9	3.44-1.04 - 2.77

Memory

4 endpoints

Secondary/protocol endpoint

Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia

Time frame:Week 4-20 post baseline

descriptive

Secondary/protocol endpoint

Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20

Time frame:Week 4-20 post Baseline

event count, event

Secondary/registry result

Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - First Part: Total Dementia

Time frame:Week 4-20 post baseline

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
MemantineWeek 4n=17 Participants	-2.3	7.64
Week 8n=17 Participants	-0.3	5.31
Week 12n=17 Participants	-1.3	4.48
Week 16n=17 Participants	0.7	5.39
Week 20n=17 Participants	1.4	4.2

Secondary/registry result

Change of Nurses' Observation Scale for Geriatric Patients [NOSGER] Total Score Value From Baseline to Week 4, 8, 12, 16, and/or 20

Time frame:Week 4-20 post Baseline

event count, event

Posted result

Group	Value (mean), Units on a scale	Standard deviation
MemantineWeek 4n=18 Participants	-0.4	10.9
Week 8n=18 Participants	-2.1	10.31
Week 12n=18 Participants	-5.4	13.29
Week 16n=18 Participants	-8.4	18.74
Week 20n=18 Participants	-7.9	19.02

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.

Time frame:Week 4-20 post Baseline

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Secondary/registry result

Change of Modified Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADLB19) Score Value From Baseline to Week 4, 8, 12, 16, and/or 20.

Time frame:Week 4-20 post Baseline

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Posted result

Group	Value (mean), Units on a Scale	Standard deviation
MemantineWeek 4n=18 Participants	-0.7	6.33
Week 8n=18 Participants	2.2	8.09
Week 12n=18 Participants	3.8	11.07
Week 16n=18 Participants	3.8	11.27
Week 20n=18 Participants	2.4	11.08

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression

Time frame:Week 4-20 post Baseline

descriptive

Secondary/protocol endpoint

Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.

Time frame:Week 8-20 post Baseline

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change of "Test for the Early Detection of Dementia With Discrimination From Depression [TE4D]" Score Value From Baseline to Week 4, 8, 12, 16, and/or 20 - Second Part: Total Depression

Time frame:Week 4-20 post Baseline

descriptive

Posted result

Group	Value (mean), units on a scale	Standard deviation
MemantineWeek 4n=17 Participants	2.5	4.84
Week 8n=17 Participants	1.6	3.97
Week 12n=17 Participants	-0.1	3.26
Week 16n=17 Participants	-0.2	2.07
Week 20n=17 Participants	-0.4	2.09

Secondary/registry result

Change in the VAS Score From Baseline to Week 8, 12, 16 and/or 20.

Time frame:Week 8-20 post Baseline

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), Units on a scale [cm]	Standard deviation
MemantineWeek 8n=18 Participants	-1.5	1.94
Week 12n=18 Participants	-1.7	2.53
Week 16n=18 Participants	-1.2	2.86
Week 20n=18 Participants	-1.4	2.46

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Maximum Dose Reduction of Antipsychotics (AP) in Percent of Defined Daily Dose (DDD) From Baseline to a Post-baseline Visit at Which the Value of the Visual Analogue Scale (VAS) Compared With the Baseline Value Was =< 15 Percent.

Time frame:Week 8-20 post baseline

descriptive

Primary/registry result/low confidence

Time frame:Week 8-20 post baseline

descriptive

Posted result

Group	Value (mean), Percent of daily dose [DDD]	Reported spread / bounds
Memantinen=19 Participants	-13.9	13.58-20.4 - -7.36

p0.22626t-test, 2 sided

Two-side, paired t-test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline

p0.34192Wilcoxon signed rank test

Wilcoxon signed rank test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline

Secondary/protocol endpoint/low confidence

Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.

Time frame:Week 8-20 post Baseline

descriptive

Secondary/registry result/low confidence

Reduction of Antipsychotic Drug Dose From Baseline to Week 8, 12, 16 and/or 20.

Time frame:Week 8-20 post Baseline

descriptive

Posted result

Group	Value (mean), Percent of daily dose [DDD]	Standard deviation
MemantineWeek 8n=15 Participants	-4.4	5.53
Week 12n=15 Participants	-8.2	12.38
Week 16n=15 Participants	-10.6	13.49
Week 20n=15 Participants	-14.9	15.05

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.