NCT00127114

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2007

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

August 3, 2005

Last Update Submit

August 10, 2017

Conditions

Dementia

Keywords

Behavioral disturbanceFrontotemporal dementiaDementiaAmantadineBehavioral disturbance due to frontotemporal dementia

Outcome Measures

Primary Outcomes (1)

  • Frontal Behavioral Inventory, disinhibition subscale

    6 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Amantadine

EXPERIMENTAL
Drug: Amantadine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AmantadineDRUG
Amantadine
PlaceboDRUG
Placebo

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baltimore, Maryland, 21287, United States

Location

Related Publications (8)

  • Drayton SJ, Davies K, Steinberg M, Leroi I, Rosenblatt A, Lyketsos CG. Amantadine for executive dysfunction syndrome in patients with dementia. Psychosomatics. 2004 May-Jun;45(3):205-9. doi: 10.1176/appi.psy.45.3.205.

    PMID: 15123844BACKGROUND

  • O'Suilleabhain P, Dewey RB Jr. A randomized trial of amantadine in Huntington disease. Arch Neurol. 2003 Jul;60(7):996-8. doi: 10.1001/archneur.60.7.996.

    PMID: 12873857BACKGROUND

  • Verhagen Metman L, Morris MJ, Farmer C, Gillespie M, Mosby K, Wuu J, Chase TN. Huntington's disease: a randomized, controlled trial using the NMDA-antagonist amantadine. Neurology. 2002 Sep 10;59(5):694-9. doi: 10.1212/wnl.59.5.694.

    PMID: 12221159BACKGROUND

  • Van Reekum R, Bayley M, Garner S, Burke IM, Fawcett S, Hart A, Thompson W. N of 1 study: amantadine for the amotivational syndrome in a patient with traumatic brain injury. Brain Inj. 1995 Jan;9(1):49-53. doi: 10.3109/02699059509004571.

    PMID: 7874096BACKGROUND

  • Imamura T, Takanashi M, Hattori N, Fujimori M, Yamashita H, Ishii K, Yamadori A. Bromocriptine treatment for perseveration in demented patients. Alzheimer Dis Assoc Disord. 1998 Jun;12(2):109-13. doi: 10.1097/00002093-199806000-00009.

    PMID: 9651140BACKGROUND

  • Kertesz A, Davidson W, McCabe P, Munoz D. Behavioral quantitation is more sensitive than cognitive testing in frontotemporal dementia. Alzheimer Dis Assoc Disord. 2003 Oct-Dec;17(4):223-9. doi: 10.1097/00002093-200310000-00005.

    PMID: 14657786BACKGROUND

  • McDowell S, Whyte J, D'Esposito M. Differential effect of a dopaminergic agonist on prefrontal function in traumatic brain injury patients. Brain. 1998 Jun;121 ( Pt 6):1155-64. doi: 10.1093/brain/121.6.1155.

    PMID: 9648550BACKGROUND

  • Sjogren M, Minthon L, Passant U, Blennow K, Wallin A. Decreased monoamine metabolites in frontotemporal dementia and Alzheimer's disease. Neurobiol Aging. 1998 Sep-Oct;19(5):379-84. doi: 10.1016/s0197-4580(98)00086-4.

    PMID: 9880039BACKGROUND

MeSH Terms

Conditions

DementiaMental DisordersFrontotemporal Dementia

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • David M Blass, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2005

First Posted

August 5, 2005

Study Start

September 1, 2005

Primary Completion

July 26, 2007

Study Completion

July 26, 2007

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

US(1)