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Treatment Study of Frontotemporal Dementia

Primary Purpose

Frontotemporal Lobar Degeneration

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Frontotemporal Lobar Degeneration focused on measuring Frontotemporal Dementia, Alzheimer's Disease, Atypical Antipsychotic, Stimulant, Apathy, Disinhibition, Antipsychotic, Biomarkers, Dementia, FTD

Eligibility Criteria

45 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: FTD as diagnosed by the Lund-Manchester criteria including patients with diagnoses of Semantic Dementia or Primary Progressive Aphasia. Ages 45 to 95 years old. Mild-to-moderate (CDR 1 to 2) FTD with an assigned durable power of attorney. EXCLUSION CRITERIA: Diagnosis of any form of dementia besides FTD, including AD, Lewy body dementia, vascular dementia, dementia associated with Parkinson's disease, Corticobasal Degeneration and Progressive Supranuclear Palsy. Severe dementia (CDR 3). Known allergy or serious adverse reaction to quetiapine or dextroamphetamine. Patient is already receiving a stimulant (methylphenidate, dextroamphetamine, pemoline, or modafinil), or an antipsychotic medication, typical or atypical, including prochlorperazine and metoclopromide. Patients taking any of the following medications because of their potential interaction with dextroamphetamine: MAO use currently or within 14 days prior to start of study, Furazolidone, Guanethidine, norepinephrine, sibutramine, tricyclic antidepressants, carbonic anhydrase inhibitors. Patients taking the following medications because of their potential interaction with quetiapine: Carbamazepine, clozapine, lithium, thioridazine. History of CVA, or at significantly increased risk for CVA (e.g., atrial fibrillation, recent TIA etc.). Symptomatic cardiovascular disease (i.e., angina, claudication, TIAs, syncope), uncontrolled hyper or hypotension, or a tic disorder. Any medical contraindication to performing the procedures involved in the study including blood draws or lumbar puncture. We will require a woman of child-bearing age to have a pregnancy test prior to starting the study medications and to use contraception during the course of the study. Patients with a previous negative trial of a stimulant. Patients with a history of severe psychosis. Patients with a history of recent substance abuse. Patients with QTc prolongation on a baseline EKG. A score of 2 or less on the Communication Functional Ratings - Swallowing Domain.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 31, 2004
Last Updated
June 30, 2017
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00088751
Brief Title
Treatment Study of Frontotemporal Dementia
Official Title
Treatment Study for Frontotemporal Dementia
Study Type
Observational

2. Study Status

Record Verification Date
June 1, 2009
Overall Recruitment Status
Completed
Study Start Date
July 23, 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1, 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
Objectives. The proposed clinical study has two goals: First, to assess the efficacy of a central nervous system stimulant and an atypical antipsychotic in treating the behavioral symptoms of FTD and second, to further characterize the biological markers, including genetic, imaging, and CSF proteins, of FTD in relation to our existing group of Alzheimer's patients. Rationale. Frontotemporal dementia (FTD) is increasingly recognized as an important neuropsychiatric disorder. Symptoms of FTD include disinhibition, impulsivity, apathy, affective lability, and language dysfunction. The clinical syndrome is associated with frontal and/or anterior temporal atrophy on imaging and autopsy. Levels of the CSF proteins tau and (Beta)-amyloid 1-42, shown to have diagnostic utility in patients with Alzheimer's Disease (AD), have also been found to be abnormal in FTD. FTD is less associated with APOE genotype than AD, however some familial cases of FTD are associated with specific mutations in the gene encoding the tau protein. Currently, no treatments have been proven to be effective for altering the course or clinical symptoms of FTD. Design. Study subjects will include 50 male and female patients with mild-moderate frontotemporal dementia recruited from participants in NINDS protocol 02-N-0001. In a double-blinded crossover 11-week study without a placebo control, patients will be treated with a stimulant (dextroamphetamine) and an atypical antipsychotic (quetiapine). The primary outcome measures will be the Neuropsychiatric Inventory and the Clinical Global Impression of Change. Cerebrospinal fluid, cognitive and genetic measures, brain MRIs, and side effects scales will also be collected.
Detailed Description
Objectives. The goal of the proposed clinical study is to assess the efficacy of a central nervous system stimulant and an atypical antipsychotic in treating the behavioral symptoms of FTD. Rationale. Frontotemporal dementia (FTD) is increasingly recognized as an important neuropsychiatric disorder. Symptoms of FTD include disinhibition, impulsivity, apathy, affective lability, and language dysfunction. The clinical syndrome is associated with frontal and/or anterior temporal atrophy on imaging and autopsy. Currently, no treatments have been proven to be effective for altering the course or clinical symptoms of FTD. Design. Study subjects will include 20 male and female patients with mild-moderate frontotemporal dementia recruited from participants in NINDS protocols 02-N-0001 and 81-N-0010. In a double-blinded crossover 11-week study without a placebo control, patients will be treated with a stimulant (dextroamphetamine) and an atypical antipsychotic (quetiapine). The primary outcome measures will be the Neuropsychiatric Inventory and the Clinical Global Impression of Change. Cognitive measures and side effects scales will also be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Lobar Degeneration
Keywords
Frontotemporal Dementia, Alzheimer's Disease, Atypical Antipsychotic, Stimulant, Apathy, Disinhibition, Antipsychotic, Biomarkers, Dementia, FTD

7. Study Design

Enrollment
20 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: FTD as diagnosed by the Lund-Manchester criteria including patients with diagnoses of Semantic Dementia or Primary Progressive Aphasia. Ages 45 to 95 years old. Mild-to-moderate (CDR 1 to 2) FTD with an assigned durable power of attorney. EXCLUSION CRITERIA: Diagnosis of any form of dementia besides FTD, including AD, Lewy body dementia, vascular dementia, dementia associated with Parkinson's disease, Corticobasal Degeneration and Progressive Supranuclear Palsy. Severe dementia (CDR 3). Known allergy or serious adverse reaction to quetiapine or dextroamphetamine. Patient is already receiving a stimulant (methylphenidate, dextroamphetamine, pemoline, or modafinil), or an antipsychotic medication, typical or atypical, including prochlorperazine and metoclopromide. Patients taking any of the following medications because of their potential interaction with dextroamphetamine: MAO use currently or within 14 days prior to start of study, Furazolidone, Guanethidine, norepinephrine, sibutramine, tricyclic antidepressants, carbonic anhydrase inhibitors. Patients taking the following medications because of their potential interaction with quetiapine: Carbamazepine, clozapine, lithium, thioridazine. History of CVA, or at significantly increased risk for CVA (e.g., atrial fibrillation, recent TIA etc.). Symptomatic cardiovascular disease (i.e., angina, claudication, TIAs, syncope), uncontrolled hyper or hypotension, or a tic disorder. Any medical contraindication to performing the procedures involved in the study including blood draws or lumbar puncture. We will require a woman of child-bearing age to have a pregnancy test prior to starting the study medications and to use contraception during the course of the study. Patients with a previous negative trial of a stimulant. Patients with a history of severe psychosis. Patients with a history of recent substance abuse. Patients with QTc prolongation on a baseline EKG. A score of 2 or less on the Communication Functional Ratings - Swallowing Domain.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3941052
Citation
Woods SW, Tesar GE, Murray GB, Cassem NH. Psychostimulant treatment of depressive disorders secondary to medical illness. J Clin Psychiatry. 1986 Jan;47(1):12-5.
Results Reference
background
PubMed Identifier
2567730
Citation
Satel SL, Nelson JC. Stimulants in the treatment of depression: a critical overview. J Clin Psychiatry. 1989 Jul;50(7):241-9.
Results Reference
background
PubMed Identifier
9144102
Citation
Galynker I, Ieronimo C, Miner C, Rosenblum J, Vilkas N, Rosenthal R. Methylphenidate treatment of negative symptoms in patients with dementia. J Neuropsychiatry Clin Neurosci. 1997 Spring;9(2):231-9. doi: 10.1176/jnp.9.2.231.
Results Reference
background

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Treatment Study of Frontotemporal Dementia

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