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CompletedPhase 1

Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)

A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD)

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Asset

Sertraline

Listed sites

Recruiting sites

Enrollment

Study population

Mixed / unspecified dementia

Key I/E criterion

Primary endpoint

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

Secondary98-N-0046

Org study ID980046

NCT IDNCT00001777

Timeline

Milestones

Study start1997-12 (month precision)

Study completion2000-05 (month precision)

Study first posted2002-12-10estimated

Last update posted2008-03-04estimated

Assets

Drug assets

Sertraline

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Characterized as having behavioral manifestations using a standardized neuropsychiatric scale and interview.

FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral test battery.

Patients must be able to be tested and cooperative with the procedures required in this protocol.

No contraindications to the use of Sertraline.

No medical conditions that can reasonably be expected to subject the patient to unwarranted risk (e.g., cancer) or require frequent changes in medication. Well-controlled medical conditions such as hypertension and diabetes will not be excluded.

Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age.

No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Not using any psychotropic medication which cannot be stopped 4 weeks before the study.

Endpoints (0)

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.

No endpoints recorded for this trial.

Publications (3)

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 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.