Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2005-04-30
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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quinacrine
Quinacrine
100mg by mouth three times a day
placebo
Placebo
100mg by mouth three times a day
Interventions
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Quinacrine
100mg by mouth three times a day
Placebo
100mg by mouth three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Able to swallow
* Able to follow simple one-step commands
* Have had a brain MRI within 6 months and an EEG within 3 months ruling out other etiologies such as masses, strokes, or non-convulsive status epilepticus
* Consent to autopsy in the event of their death during or after the study
Exclusion Criteria
* History of other disease requiring regular supportive care
* Liver disease
* Active alcoholism
* Bone marrow suppression
* Severe hypotension
* Severe psoriasis
* Poorly controlled diabetes
* Women who are pregnant or breast-feeding
* Men, or women of childbearing age, not practicing reliable contraception
* Serious allergies to quinacrine or other acridines
* Current or recent use of quinacrine (within 6 months)
* \< 18 years of age
* Any other contraindication to taking quinacrine
* Genetic form of prion disease is identified prior to study enrollment
* Current use of anti-arrhythmics (at discretion of investigator)
* G6PD (Glucose 6-Phosphate Dehydrogenase) deficiency (at discretion of investigator)
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Michael Geschwind, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UCSF Memory & Aging Center, University of California, San Francisco
Bruce L. Miller, MD
Role: PRINCIPAL_INVESTIGATOR
UCSF Memory & Aging Center, University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Prusiner SB. Prions. Proc Natl Acad Sci U S A. 1998 Nov 10;95(23):13363-83. doi: 10.1073/pnas.95.23.13363.
Korth C, May BC, Cohen FE, Prusiner SB. Acridine and phenothiazine derivatives as pharmacotherapeutics for prion disease. Proc Natl Acad Sci U S A. 2001 Aug 14;98(17):9836-41. doi: 10.1073/pnas.161274798.
Scoazec JY, Krolak-Salmon P, Casez O, Besson G, Thobois S, Kopp N, Perret-Liaudet A, Streichenberger N. Quinacrine-induced cytolytic hepatitis in sporadic Creutzfeldt-Jakob disease. Ann Neurol. 2003 Apr;53(4):546-7. doi: 10.1002/ana.10530. No abstract available.
Wallace DJ. Is there a role for quinacrine (Atabrine) in the new millennium? Lupus. 2000;9(2):81-2. doi: 10.1191/096120300678828163. No abstract available.
Engel GL. Quinacrine effects on the central nervous system. JAMA. 1966 Aug 8;197(6):515. No abstract available.
Geschwind MD, Kuo AL, Wong KS, Haman A, Devereux G, Raudabaugh BJ, Johnson DY, Torres-Chae CC, Finley R, Garcia P, Thai JN, Cheng HQ, Neuhaus JM, Forner SA, Duncan JL, Possin KL, Dearmond SJ, Prusiner SB, Miller BL. Quinacrine treatment trial for sporadic Creutzfeldt-Jakob disease. Neurology. 2013 Dec 3;81(23):2015-23. doi: 10.1212/WNL.0b013e3182a9f3b4. Epub 2013 Oct 11.
Related Links
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UCSF Memory \& Aging Center
UCSF Institute for Neurodegenerative Diseases
Other Identifiers
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IA0083
Identifier Type: -
Identifier Source: org_study_id
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