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

August 10, 2017 updated by: Johns Hopkins University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School of Medicine, Outpatient General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: Amantadine
Drug: Amantadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frontal Behavioral Inventory, disinhibition subscale
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: David M Blass, M.D., Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2005

Primary Completion (ACTUAL)

July 26, 2007

Study Completion (ACTUAL)

July 26, 2007

Study Registration Dates

First Submitted

August 3, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (ESTIMATE)

August 5, 2005

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04033101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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