Treatment Study for Frontotemporal Dementia
Colección de datos
Enfermedades del Sistema Nervioso Central+8
+ Afasia
+ Trastornos de la Comunicación
Resumen
Fecha de inicio: 23 de julio de 2004
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 45 a 95 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
* INCLUSION CRITERIA: 1. FTD as diagnosed by the Lund-Manchester criteria including patients with diagnoses of Semantic Dementia or Primary Progressive Aphasia. 2. Ages 45 to 95 years old. 3. Mild-to-moderate (CDR 1 to 2) FTD with an assigned durable power of attorney. EXCLUSION CRITERIA: 1. 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. 2. Severe dementia (CDR 3). 3. Known allergy or serious adverse reaction to quetiapine or dextroamphetamine. 4. Patient is already receiving a stimulant (methylphenidate, dextroamphetamine, pemoline, or modafinil), or an antipsychotic medication, typical or atypical, including prochlorperazine and metoclopromide. 5. 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. 6. Patients taking the following medications because of their potential interaction with quetiapine: Carbamazepine, clozapine, lithium, thioridazine. 7. History of CVA, or at significantly increased risk for CVA (e.g., atrial fibrillation, recent TIA etc.). 8. Symptomatic cardiovascular disease (i.e., angina, claudication, TIAs, syncope), uncontrolled hyper or hypotension, or a tic disorder. 9. Any medical contraindication to performing the procedures involved in the study including blood draws or lumbar puncture. 10. 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. 11. Patients with a previous negative trial of a stimulant. 12. Patients with a history of severe psychosis. 13. Patients with a history of recent substance abuse. 14. Patients with QTc prolongation on a baseline EKG. 15. A score of 2 or less on the Communication Functional Ratings - Swallowing Domain.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesVer ubicación