CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

NCT ID: NCT00183092

Last Updated: 2014-06-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Creutzfeldt-Jakob Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

quinacrine

Group Type EXPERIMENTAL

Quinacrine

Intervention Type DRUG

100mg by mouth three times a day

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100mg by mouth three times a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quinacrine

100mg by mouth three times a day

Intervention Type DRUG

Placebo

100mg by mouth three times a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Atabrine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Prusiner SB. Prions. Proc Natl Acad Sci U S A. 1998 Nov 10;95(23):13363-83. doi: 10.1073/pnas.95.23.13363.

Reference Type BACKGROUND
PMID: 9811807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11504948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12666126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10787002 (View on PubMed)

Engel GL. Quinacrine effects on the central nervous system. JAMA. 1966 Aug 8;197(6):515. No abstract available.

Reference Type BACKGROUND
PMID: 5952734 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24122181 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://memory.ucsf.edu

UCSF Memory \& Aging Center

http://ind.universityofcalifornia.edu/

UCSF Institute for Neurodegenerative Diseases

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P01AG021601

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0083

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pioglitazone in Alzheimer Disease
NCT00982202 COMPLETED PHASE2