Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)

Sponsor

Johns Hopkins University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00127114

Collaborator

(none)

Enrollment

Location

Arms

22.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to test whether or not the medication amantadine is effective in reducing behavioral disturbances in patients with frontotemporal dementia.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Drug: Amantadine Drug: Placebo	Phase 4

Detailed Description

Behavioral disturbances are a major cause of morbidity in frontotemporal dementia (FTD), yet little is known about the effectiveness of medications to treat these disturbances. Preliminary data suggests that the dopaminergic agent amantadine may reduce these disturbances. This 6-week, prospective, randomized, placebo-controlled trial will compare amantadine to placebo to assess its effectiveness in reducing behavioral symptoms.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)

Actual Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jul 26, 2007

Actual Study Completion Date :

Jul 26, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amantadine	Drug: Amantadine
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Amantadine

Drug: Amantadine

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Frontal Behavioral Inventory, disinhibition subscale [6 weeks]

Secondary Outcome Measures

Frontal Behavior Inventory, total score [6 weeks]
Neuropsychiatric Inventory [6 weeks]
Apathy Evaluation Scale [6 weeks]
Cognitive measures - Mini Mental State Exam (MMSE), Trails Making Test A&B (Trails A&B), Verbal fluency, and Stroop test [6 weeks]
Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) measures [6 weeks]
Zarit Burden Interview [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.