Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD) - Alzheimer’s Disease & Related Dementias Atlas

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 ID04033101

NCT IDNCT00127114

Timeline

Milestones

Study first posted2005-08-05estimated

Study start2005-09actual (month precision)

Primary completion2007-07-26actual

Study completion2007-07-26actual

Last update posted2017-08-14actual

Assets

Drug assets

Amantadine

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age40 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Frontotemporal dementia meeting diagnostic criteria of the Report of the Work Group on Frontotemporal Dementia and Pick's Disease (McKhann et al, 2001). Diagnosis will be established by clinical interview by a geriatric psychiatrist or neuropsychiatrist, experienced with the diagnosis of FTD. Patients with the language presentation of FTD will be enrolled if their behavioral disturbance meets the inclusion criteria. Use of these diagnostic criteria would allow for enrollment of patients who in a clinical setting carry the diagnosis of: semantic dementia, primary progressive aphasia, cortical-basal degeneration, progressive supranuclear palsy, (amyotrophic lateral sclerosis (ALS) with dementia, and Pick's disease, as all of these diagnoses are now classified under the rubric of FTD.

•Frontal Behavioral Inventory (FBI) disinhibition subscale score of >16 (Kertesz et al,1997; Kertesz et al 2000). Explanation of this subscale is found under outcome measures.

•Men, women and minority groups will be included, ages 40-90 years old.

•Judged by the attending psychiatrist to be in sufficiently good health so as to be treated using the study protocol in usual outpatient care circumstances.

•Patient, caregivers and or legal representatives provide informed consent for participation in the study, using standard Johns Hopkins Division of Geriatric Psychiatry and Neuropsychiatry procedures.

•Caregiver is available who spends at least 10 hours per week with the patient and is able and willing to accompany the patient in the course of the study and to provide collateral information

Exclusion criteria

•Presence of a brain disease that might otherwise fully explain the presence of dementia or behavior disturbance, such as stroke, Parkinson's disease, traumatic brain injury, multiple sclerosis, and the like.

•Treatment with amantadine is contraindicated in the opinion of the study attending psychiatrist. Examples of this would be patients with advanced heart, liver or kidney disease or a seizure disorder. Creatinine clearance >50mL/min will be required, calculated using the Cockcroft-Gault equation.

•Failure of treatment with amantadine for behavior disturbance of FTD in the past.

•Treatment with a medication that would prohibit the safe concurrent use of amantadine.

•Ongoing regular alcohol use and an unwillingness to stop drinking alcohol during the study period.

•Pregnancy or lactation.

Endpoints (7)

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

Behavior / neuropsychiatric

3

Global cognition

1

Function / daily living

1

Caregiver / quality of life

1

Other (unclassified)

1

Global cognition

1 endpoint

Secondary/protocol endpoint

Cognitive measures - Mini Mental State Exam (MMSE), Trails Making Test A&B (Trails A&B), Verbal fluency, and Stroop test

Time frame:6 weeks

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) measures

Time frame:6 weeks

descriptive

Behavior / neuropsychiatric

3 endpoints

Secondary/protocol endpoint

Frontal Behavior Inventory, total score

Time frame:6 weeks

descriptive

Secondary/protocol endpoint

Neuropsychiatric Inventory

Time frame:6 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Apathy Evaluation Scale

Time frame:6 weeks

descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Zarit Burden Interview

Time frame:6 weeks

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Frontal Behavioral Inventory, disinhibition subscale

Time frame:6 weeks

descriptive

Publications (8)

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.