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CompletedPhase 4Results posted

Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training

Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial

Lead sponsor

NYU Langone Health

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 3-14

Primary endpoints

•Clinician Interview-Based Assessment of Change Plus Caregiver Input•ADCS-Activities of Daily Living (ADCS-ADL)

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

Org study IDH12444-01 A

Other grantNAM MD 18Forest Laboratories

NCT IDNCT00120874

Timeline

Milestones

Study first posted2005-07-19estimated

Study start2006-08 (month precision)

Primary completion2011-11actual (month precision)

Study completion2011-11actual (month precision)

Results first posted2016-07-14estimated

Last update posted2016-10-25estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients, 50 years of age or greater, residing in the community

•Presence of a family and/or professional caregiver willing and able to participate in all aspects of this study

•A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al., Neurology,1984;34: 939-944) criteria

•A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA diagnostic criteria for Alzheimer's disease

•Mini-Mental State Examination scores of 3-14

•Global Deterioration Scale stages of 5 or 6

•A stage of 6a or greater on the Functional Assessment Staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living

Exclusion criteria

•Non-English speaking patients and/or caregivers

•Subjects with a diagnosis of dementia due to conditions other than Alzheimer's disease.

•Subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified Hachinski Ischemic Rating scale

•Patients with a major depressive disorder

•Patients with clinically significant laboratory abnormalities

•Patients receiving investigational pharmacologic agents

Endpoints (32)

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

Global cognition

Memory

Caregiver / quality of life

Function / daily living

Other (unclassified)

Global cognition

8 endpoints

Secondary/protocol endpoint

Change From Baseline of the Severe Impairment Battery (SIB)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of the Severe Impairment Battery (SIB)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of the Mini-Mental State Examination (MMSE)

Time frame:Baseline to 28 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of the Mini-Mental State Examination (MMSE)

Time frame:Baseline to 52 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline of the Severe Impairment Battery (SIB)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	51.3	33.843
Memantine Alonen=9 Participants	54	37.002

Secondary/registry result

Change From Baseline of the Severe Impairment Battery (SIB)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	45.1	33.365
Memantine Alonen=9 Participants	48	37.353

Secondary/registry result

Change From Baseline of the Mini-Mental State Examination (MMSE)

Time frame:Baseline to 28 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	6.7	5.143
Memantine Alonen=9 Participants	8.4	5.816

Secondary/registry result

Change From Baseline of the Mini-Mental State Examination (MMSE)

Time frame:Baseline to 52 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	6.7	4.138
Memantine Alonen=9 Participants	6.7	5.477

Memory

8 endpoints

Secondary/protocol endpoint

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

Time frame:Baseline to 28 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

Time frame:Baseline to 28 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

Time frame:Baseline to 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

Time frame:Baseline to 52 weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

Time frame:Baseline to 28 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	24.7	9.945
Memantine Alonen=9 Participants	34.9	9.515

Secondary/registry result

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

Time frame:Baseline to 28 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	2.0	2.582
Memantine Alonen=9 Participants	10.7	14.143

Secondary/registry result

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

Time frame:Baseline to 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	24.4	8.449
Memantine Alonen=9 Participants	32.4	11.4

Secondary/registry result

Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

Time frame:Baseline to 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	3.8	6.68
Memantine Alonen=9 Participants	11.4	11.599

Function / daily living

4 endpoints

Primary/protocol endpoint

Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

Time frame:Baseline to 28 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

Time frame:Baseline to 52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Primary/registry result

Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

Time frame:Baseline to 28 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	21.9	8.034
Memantine Alonen=9 Participants	9.6	6.041

Primary/registry result

Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

Time frame:Baseline to 52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	18.5	8.045
Memantine Alonen=9 Participants	7.6	6.766

Caregiver / quality of life

8 endpoints

Primary/protocol endpoint

Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	2.3	1.16
Memantine Alonen=9 Participants	5.22	1.56

Primary/registry result

Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	2.1	1.45
Memantine Alonen=9 Participants	6	1.32

Secondary/protocol endpoint

Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	7.2	5.308
Memantine Alonen=9 Participants	23.7	14.952

Secondary/registry result

Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	8.1	5.131
Memantine Alonen=9 Participants	21.2	11.893

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

Time frame:Baseline to 28 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	6.16	0.631
Memantine Alonen=9 Participants	6.67	0.246

Secondary/registry result/low confidence

Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

Time frame:Baseline to 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Memantine + CIPCM Programn=10 Participants	6.5	0.254
Memantine Alonen=9 Participants	6.84	0.279

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.