TerminatedPhase 4

Functional Brain Imaging of Medication Treatment Response in Mild Alzheimer's Disease Patients

Functional Neuroimaging (fMRI) Biomarker of Allosteric Nicotinic Receptor Modulation in Mild Alzheimer's Disease Patients: A Razadyne vs. Aricept Dose Escalation Trial

Lead sponsor

Duke University

Assets

Donepezil / Galantamine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Brain activity patterns, as collected

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

Secondary IDGAL-EMR-4026DUMC

NCT IDNCT00369603

Org study IDPro00011149

Timeline

Milestones

Study first posted2006-08-29estimated

Study start2006-10 (month precision)

Primary completion2007-10actual (month precision)

Study completion2007-11actual (month precision)

Last update posted2013-04-11estimated

Assets

Drug assets

Donepezil Galantamine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Must meet diagnosis of mild Alzheimer's disease

•Must have a family member or caregiver who is willing to attend all study visits and provide information on your participation in the study

•If female, must be post-menopausal

•Must be able to swallow tablets

Exclusion criteria

•Metal implants or medical devises unsafe for MRI use

•Pre-menopausal female

•HIstory of recent head injury

•Significant major, life-threatening illness or injury (e.g., stroke, AIDS, etc.)

•Vascular dementia or any dementia other than Alzheimer's Disease

•History of significant alcoholism or drug abuse

•History of seizure disorder, developmental delay or major psychiatric illness

Endpoints (2)

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

Neuroimaging

Other (unclassified)

Neuroimaging

1 endpoint

Primary/protocol endpoint

Brain activity patterns, as collected via functional magnetic resonance imaging (fMRI), at rest and associated with task performance after 4 weeks of low-dose treatment and after 8-weeks of higher-dose treatment.

Time frame:4-weeks and 12-weeks

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Differences in cognitive testing and functional status at pre-treatment baseline and after completion of the 12-week treatment trial.

Time frame:baseline and 12-weeks

categorical status, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.