Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183092
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2005-09-14
Brief Title:
CJD Creutzfeldt-Jakob Disease Quinacrine Study
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Creutzfeldt-Jakob disease CJDis 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 5050 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
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 5050 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01AG021601 | NIH | None | httpsreporternihgovquickSearchP01AG021601 |