Frontotemporal Lobar Degeneration Clinical Trial
Official title:
Treatment Study for 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, 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.
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.
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