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NCT00088751 · ClinicalTrials.gov registry record
Treatment Study of Frontotemporal Dementia
A clinical trial of Frontotemporal Lobar Degeneration, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT00088751 is a study of Frontotemporal Lobar Degeneration that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 20 participants, below the 407-participant average among 6 other Frontotemporal Lobar Degeneration trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00088751, a study of Frontotemporal Lobar Degeneration, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2004-07-23 |
| Est. Completion | 2009-06-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088751
The ClinicalTrials.gov registry entry for NCT00088751 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 407-participant average among 6 other Frontotemporal Lobar Degeneration trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Frontotemporal Lobar Degeneration appearing as the primary indexed condition, and to 0 interventions.
NCT00088751 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00088751 about?
NCT00088751 is a clinical study titled "Treatment Study of Frontotemporal Dementia". 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...
What is the current status of trial NCT00088751?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2004-07-23. Estimated completion is 2009-06-01.
What conditions does trial NCT00088751 study?
This clinical trial studies the following conditions: Frontotemporal Lobar Degeneration.
Who is sponsoring clinical trial NCT00088751?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088751 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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