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

Last updated: August 10, 2017
Sponsor: Johns Hopkins University
Overall Status: Trial Not Available

Phase

4

Condition

Dementia

Frontotemporal Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00127114
04033101
  • Ages 40-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  • 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 betreated using the study protocol in usual outpatient care circumstances.

  • Patient, caregivers and or legal representatives provide informed consent forparticipation in the study, using standard Johns Hopkins Division of GeriatricPsychiatry and Neuropsychiatry procedures.

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

Exclusion

Exclusion Criteria:

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

  • Treatment with amantadine is contraindicated in the opinion of the study attendingpsychiatrist. Examples of this would be patients with advanced heart, liver or kidneydisease 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 thestudy period.

  • Pregnancy or lactation.

Study Design

Study Start date:
September 01, 2005
Estimated Completion Date:
July 26, 2007

Study 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.

Connect with a study center

  • Johns Hopkins University School of Medicine, Outpatient General Clinical Research Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

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