CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

NCT00183092 | Completed Phase 2 Results DMC

• 2 other identifiers: IA0083P01AG021601
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Creutzfeldt-Jakob Disease

Keywords

dementia; spongiform encephalopathy; nervous system disorder; acridine; prion; neuropharmacologic agent

Outcome Measures

Primary Outcomes (1)

• Primary Survival

  Participants alive after 2 months on study treatment

  Randomization to Month-2

Secondary Outcomes (7)

• Change in Mini-Mental State Examination (MMSE) After 2 Months

  Baseline to Month-2

• Barthel Score Change After 2 Months

  baseline, 2 months

• Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months

  Baseline, 2 months

• Change in Rankin Score After 2 Months

  Baseline, 2 months

• ADAS-Cog Change After 2 Months Among Survivors

  Baseline, 2 months

Study Arms (2)

quinacrine

EXPERIMENTAL

Drug: Quinacrine

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Quinacrine DRUG

100mg by mouth three times a day

Also known as: Atabrine

quinacrine

Placebo DRUG

100mg by mouth three times a day

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (6)

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

  PMID: 9811807 BACKGROUND

• 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.

  PMID: 11504948 BACKGROUND

• 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.

  PMID: 12666126 BACKGROUND

• 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.

  PMID: 10787002 BACKGROUND

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

  PMID: 5952734 BACKGROUND

• 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.

  PMID: 24122181 DERIVED

Related Links

• UCSF Memory \& Aging Center
• UCSF Institute for Neurodegenerative Diseases

MeSH Terms

Conditions

Creutzfeldt-Jakob Syndrome; Dementia; Prion Diseases; Nervous System Diseases; Insomnia, Fatal Familial

Interventions

Quinacrine

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurodegenerative Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael Geschwind, MD, PhD
• Organization: UCaliforniaSF

mgeschwind@memory.ucsf.edu

415-476-2901

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 9, 2014
• Results First Posted: May 29, 2014

Record last verified: 2014-05

Locations

US (1)