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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00183092 |
The purpose of this clinical trial is to determine the effectiveness of the medication quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).
Condition | Intervention | Phase |
---|---|---|
Creutzfeldt-Jakob Disease |
Drug: Quinacrine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Novel Therapeutics For Prion Diseases: A Randomized, Double-Blinded, Placebo-Controlled Study of the Efficacy of Quinacrine in the Treatment of Sporadic Creutzfeldt-Jakob Disease |
Estimated Enrollment: | 60 |
Study Start Date: | April 2005 |
Creutzfeldt-Jakob disease (CJD)is a rapidly progressive, invariably fatal and untreatable neurodegenerative disease with a mean duration of about eight months. Beyond the debilitating cognitive and motor deficits that accompany CJD, the difficulty in treating behavioral and mood disturbances and the rapidity of its course compound its tragedy. Recent results from experiments show that, at physiological concentrations, the anti-malarial drug quinacrine permanently clears abnormal prion proteins from cell culture. The demonstrated efficacy of quinacrine in cell culture, its relative safety and well known side-effects in the clinical setting, and the universal fatality of CJD justify quinacrine as an immediate candidate for the treatment of CJD.
The purpose of this clinical trial is to determine the efficacy of the medication quinacrine on survival in sporadic CJD (sCJD). This will be accomplished by bringing approximately 60 patients with probable or definite sCJD over approximately three years to UCSF for evaluation and initiation of a randomized, double-blinded, placebo-controlled (delayed treatment start) treatment study of quinacrine. Each patient will have a 50:50 chance of being placed on quinacrine or placebo upon study enrollment; however, all patients will be offered quinacrine after two months. Prior to study enrollment, patients will have a comprehensive clinical assessment to confirm the diagnosis of sCJD. Participants will come to UCSF for initial evaluation, potential study enrollment and, if possible, return to UCSF for follow-up at two and twelve months. Patients will receive telephone follow-up (every 2 weeks for the first two months and monthly thereafter) and local blood and testing to monitor for possible medication toxicity.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Benjamin Raudabaugh | 415-476-0670 | braudabaugh@memory.ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Gillian Devereux, MPH 415-476-0670 gdevereux@memory.ucsf.edu | |
Contact: Michael Geschwind, MD, PhD 415-476-0668 mgeschwind@memory.ucsf.edu | |
Principal Investigator: Bruce L. Miller, MD |
Principal Investigator: | Michael Geschwind, MD, PhD | UCSF Memory & Aging Center, University of California, San Francisco |
Principal Investigator: | Bruce L. Miller, MD | UCSF Memory & Aging Center, University of California, San Francisco |
Study ID Numbers: | IA0083, AG21601-03 |
Study First Received: | September 14, 2005 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00183092 |
Health Authority: | United States: Food and Drug Administration |
dementia spongiform encephalopathy nervous system disorder |
acridine prion neuropharmacologic agent |
Spongiform encephalopathy Creutzfeldt-Jakob Syndrome Central Nervous System Diseases Brain Diseases Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Central Nervous System Infections |
Mental Disorders Prion Diseases Dementia Quinacrine Creutzfeldt Jakob disease Delirium |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antiplatyhelmintic Agents Antineoplastic Agents Nervous System Diseases Anthelmintics |
Enzyme Inhibitors Pharmacologic Actions Anticestodal Agents Antimalarials Antiparasitic Agents Therapeutic Uses Antinematodal Agents |