Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088751
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-07-31
Brief Title:
Treatment Study of Frontotemporal Dementia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment Study for Frontotemporal Dementia
Status:
COMPLETED
Status Verified Date:
2009-06-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 andor 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 Alzheimers 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
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 andor 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 Alzheimers 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0247 | None | None | None |