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

This study has been withdrawn prior to enrollment.
(No funding and exclusion criteria were to stringent.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127114
First Posted: August 5, 2005
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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 Intervention Phase
Dementia Drug: Amantadine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Frontal Behavioral Inventory, disinhibition subscale [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Frontal Behavior Inventory, total score [ Time Frame: 6 weeks ]
  • Neuropsychiatric Inventory [ Time Frame: 6 weeks ]
  • Apathy Evaluation Scale [ Time Frame: 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 ]
  • Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) measures [ Time Frame: 6 weeks ]
  • Zarit Burden Interview [ Time Frame: 6 weeks ]

Enrollment: 0
Actual Study Start Date: September 2005
Study Completion Date: July 26, 2007
Primary Completion Date: July 26, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amantadine Drug: Amantadine
Placebo Comparator: Placebo Drug: Placebo

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127114


Locations
United States, Maryland
Johns Hopkins University School of Medicine, Outpatient General Clinical Research Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: David M Blass, M.D. Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00127114     History of Changes
Other Study ID Numbers: 04033101
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
Behavioral disturbance
Frontotemporal dementia
Dementia
Amantadine
Behavioral disturbance due to frontotemporal dementia

Additional relevant MeSH terms:
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Problem Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Behavioral Symptoms
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents


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