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CompletedPhase 4Results posted

Corticolimbic Degeneration and Treatment of Dementia

Lead sponsor

Washington University School of Medicine

Assets

Donepezil / Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Change of Hippocampal Volume Slope

Identifiers

Registered as

Org study ID5R01MH060883-06https://reporter.nih.gov/quickSearch/5R01MH060883-06

NCT IDNCT00768261

Timeline

Milestones

Study start2004-11 (month precision)

Study first posted2008-10-08estimated

Primary completion2009-10actual (month precision)

Study completion2009-10actual (month precision)

Last update posted2018-09-11actual

Results first posted2018-09-11actual

Assets

Drug assets

Donepezil Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1) meets National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) Alzheimer's criteria for dementia of the Alzheimer's type (DAT), 2) Clinical Dementia Rating (CDR) score of 0.5 or 1, 3) 50-80 years of age, 4) able to give informed consent or has a primary caregiver or legal guardian, who can give informed consent

Exclusion criteria

1) other psychiatric (e.g., depression) or neurological (e.g., CVA) disorders that would confound the assessment of dementia symptoms, 2) history of loss of consciousness, and 3) unstable or severe medical illness (e.g., hepatotoxicity) that would make donepezil or memantine treatment or participation in other aspects of the study unsafe.

Endpoints (4)

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

Neuroimaging

Global cognition

2 endpoints

Secondary/protocol endpoint

Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change

Time frame:two years

ADAS-Cog

event count, event

Secondary/registry result

Comparison of Combined DAT Patients' Mean (SD) Hippocampal Volume Slope (mm^3/Year) Rate of Change

Time frame:two years

ADAS-Cog

event count, event

Posted result

Group	Value (mean), (mm^3/year)	Standard deviation
Improvedleft hippocampal volume slopen=10 Participants	-70	56
right hippocampal volume slopen=10 Participants	-77	51
Worseningleft hippocampal volume slopen=11 Participants	-106	55
right hippocampal volume slopen=11 Participants	-141	78
Stableleft hippocampal volume slopen=11 Participants	-100	37
right hippocampal volume slopen=11 Participants	-105	34

p0.066ANOVA

p0.009ANOVA

p0.30ANOVA

p0.0288Repeated Measures ANOVA

RM-ANOVA on hippocampal volume slope

Neuroimaging

2 endpoints

Primary/protocol endpoint

Rate of Change of Hippocampal Volume Slope

Time frame:2 years

descriptive

Primary/registry result

Rate of Change of Hippocampal Volume Slope

Time frame:2 years

descriptive

Posted result

Group	Value (mean), mm^3/year	Standard deviation
1 Very Mild to Mild DAT Untreatedleft hippocampal volume slopen=14 Participants	-70.2418748	31.4801034
right hippocampal volume slopen=14 Participants	-99.9437062	65.1619838
2 Very Mild to Mild DAT Treated With Donepezilleft hippocampal volume slopen=18 Participants	-88.4738591	52.2621175
right hippocampal volume slopen=18 Participants	-94.3258652	44.7959659
3 Very Mild to Mild DAT Treated With the Combinationleft hippocampal volume slopen=14 Participants	-94.0768115	48.349487
right hippocampal volume slopen=14 Participants	-125.0687876	72.5509442
4 Nondemented Comparison Subjects.left hippocampal volume slopen=56 Participants	-46.9484805	83.5825530
right hippocampal volume slopen=56 Participants	-80.0840066	130.3453711

p0.095ANOVA

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.