Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)
This study has been terminated.
(Recruitment difficulties)
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00127114
First received: August 3, 2005
Last updated: March 16, 2009
Last verified: March 2009
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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 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD) |
Resource links provided by NLM:
Genetics Home Reference related topics:
CHMP2B-related frontotemporal dementia
frontotemporal dementia with parkinsonism-17
GRN-related frontotemporal dementia
inclusion body myopathy with early-onset Paget disease and frontotemporal dementia
MedlinePlus related topics:
Dementia
U.S. FDA Resources
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Frontal Behavioral Inventory, disinhibition subscale
Secondary Outcome Measures:
- Frontal Behavior Inventory, total score
- Neuropsychiatric Inventory
- Apathy Evaluation Scale
- Cognitive measures - Mini Mental State Exam (MMSE), Trails Making Test A&B (Trails A&B), Verbal fluency, and Stroop test
- Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) measures
- Zarit Burden Interview
| Estimated Enrollment: | 52 |
| Study Start Date: | September 2005 |
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| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
Publications:
| Responsible Party: | Dr. David Mark Blass, Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00127114 History of Changes |
| Other Study ID Numbers: | 04033101 |
| Study First Received: | August 3, 2005 |
| Last Updated: | March 16, 2009 |
| Health Authority: | United States: Institutional Review Board |
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 Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive 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 Amantadine Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013