Phase 2
N=51
CJD (Creutzfeldt-Jakob Disease) Quinacrine Study
Creutzfeldt-Jakob Disease
Bottom Line
View on ClinicalTrials.gov: NCT00183092 ↗Enrolled (actual)
51
Serious AEs
54.7%
Results posted
May 2014
Primary outcome: Primary: Primary Survival — 19; 13 participants — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Quinacrine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Survival |
19; 13 | 0.43 |
| SECONDARY Change in Mini-Mental State Examination (MMSE) After 2 Months |
-6.9; -3.9 | .54 |
| SECONDARY Barthel Score Change After 2 Months |
-23.2; -13.2 | .36 |
| SECONDARY Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months |
3.2; 0.3 | .01 sig |
| SECONDARY Change in Rankin Score After 2 Months |
0.8; 0.3 | 0.03 sig |
| SECONDARY ADAS-Cog Change After 2 Months Among Survivors |
13.0; 12.6 | 0.92 |
| SECONDARY Change in Phonemic Fluency (Words Beginning With Letter "D") |
-2.4; -2.2 | 0.71 |
| SECONDARY Change in Semantic Verbal Fluency (Naming Animals) |
-3.2; -2.2 | 0.70 |
Summary
The purpose of this clinical trial is to determine the effectiveness of the medication quinacrine on survival in sporadic Creutzfeldt-Jakob disease (sCJD).
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00183092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.