CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

This study has been completed.
Sponsor:
Collaborator:
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

September 14, 2005
November 8, 2012
April 2005
June 2012   (final data collection date for primary outcome measure)
Primary Survival [ Time Frame: Randomization to Month-2 ] [ Designated as safety issue: No ]
Survival from the time of randomization
Complete list of historical versions of study NCT00183092 on ClinicalTrials.gov Archive Site
Scores on functional scales, neurological exam and functional testing [ Time Frame: Baseline to Month-2 ] [ Designated as safety issue: No ]
Scores on functional scales, neurological exam and functional testing
Not Provided
Not Provided
 
CJD (Creutzfeldt-Jakob Disease) Quinacrine Study
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

The purpose of this clinical trial is to determine the effectiveness of the medication quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Creutzfeldt-Jakob Disease
  • Drug: Quinacrine
    100mg by mouth three times a day
    Other Name: Atabrine
  • Drug: Placebo
    100mg by mouth three times a day
  • Experimental: quinacrine
    Intervention: Drug: Quinacrine
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
June 2012
June 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183092
IA0083, P01AG021601
Yes
Michael Geschwind, University of California, San Francisco
University of California, San Francisco
National Institute on Aging (NIA)
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
University of California, San Francisco
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP