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CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Michael Geschwind, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00183092
First received: September 14, 2005
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Primary Survival [ Time Frame: Randomization to Month-2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores on functional scales, neurological exam and functional testing [ Time Frame: Baseline to Month-2 ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: April 2005
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: quinacrine Drug: Quinacrine
100mg by mouth three times a day
Other Name: Atabrine
Placebo Comparator: placebo Drug: Placebo
100mg by mouth three times a day

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable or definite sCJD: Definite--biopsy confirmed sCJD; Probable--a progressive dementia with either a typical EEG or a typical MRI consistent with sCJD, and at least two of the following clinical features: myoclonus, pyramidal or extrapyramidal signs, visual symptoms, cerebellar signs, akinetic mutism, other focal higher cortical neurologic signs (e.g. neglect, apraxia, aphasia)
  • 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 significant or life-threatening disease, including: cancer; end-stage liver or renal disease; severe heart disease
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183092

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute on Aging (NIA)
Investigators
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
  More Information

Additional Information:
UCSF Memory & Aging Center  This link exits the ClinicalTrials.gov site
UCSF Institute for Neurodegenerative Diseases  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Michael Geschwind, Associate Professor of Neurology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00183092     History of Changes
Other Study ID Numbers: IA0083, P01AG021601
Study First Received: September 14, 2005
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
dementia
spongiform encephalopathy
nervous system disorder
 acridine
prion
neuropharmacologic agent

Additional relevant MeSH terms:
Creutzfeldt-Jakob Syndrome
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Prion Diseases
Central Nervous System Infections
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Quinacrine
Anticestodal Agents
Antiplatyhelmintic Agents
 Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antinematodal Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013