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Trial record 1 of 11 for:    Creutzfeldt-Jakob Disease
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CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

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ClinicalTrials.gov Identifier: NCT00183092
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : May 29, 2014
Last Update Posted : June 9, 2014
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Creutzfeldt-Jakob Disease
Interventions: Drug: Quinacrine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began in April 2005 and ended in January 2009. Subjects came from across the USA, as well as Canada, with a plurality from California, and enrolled at one U.S. clinical site (University of California, San Francisco).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
425 patients referred; 69 subjects consented/enrolled; 54 subjects eligible/randomized; 3 randomized subjects identified as carriers of PrP (prion protein) gene mutations as determined by analysis of sequence variability of the bovine prion protein gene (PRNP) and excluded from analyses.

Reporting Groups
  Description
Quinacrine Double Blind Period: 100mg Quinacrine by mouth three times a day. Open Label Period: Choice of study drug or open-label Quinacrine 100mg by mouth three times a day.
Placebo Double Blind Period: 100mg Placebo by mouth three times a day. Open Label Period: Choice of study drug or Quinacrine 100mg by mouth three times a day.
Study Drug (Quinacrine) During Open-Label Period Participants received Quinacrine during Double-Blind period and opted to continue study drug during Open-Label period
Study Drug (Placebo) During Open-Label Period Participants received Placebo during Double-Blind period and opted to continue study drug during Open-Label period

Participant Flow for 2 periods

Period 1:   Double-blind (Baseline - Month 2)
    Quinacrine   Placebo   Study Drug (Quinacrine) During Open-Label Period   Study Drug (Placebo) During Open-Label Period
STARTED   23   28   0   0 
Alive at Month 2   13   19   0   0 
Came in for Month 2 Visit   10   16   0   0 
COMPLETED   11   16   0   0 
NOT COMPLETED   12   12   0   0 

Period 2:   Open-label Period (Month 2 Until Death)
    Quinacrine   Placebo   Study Drug (Quinacrine) During Open-Label Period   Study Drug (Placebo) During Open-Label Period
STARTED   10 [1]   14 [2]   1 [3]   1 [4] 
COMPLETED   0   0   0   0 
NOT COMPLETED   10   14   1   1 
[1] Participants initially assigned to Quinacrine opted to begin open-label Quinacrine at Month 2
[2] Participants initially assigned to Placebo opted to begin open-label Quinacrine at Month 2
[3] Participants assigned to Quinacrine opted to continue assigned drug during open-label period
[4] Participants assigned to Placebo opted to continue assigned drug during open-label period



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo : 100mg by mouth three times a day
Quinacrine Quinacrine : 100mg by mouth three times a day
Total Total of all reporting groups

Baseline Measures
   Placebo   Quinacrine   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   23   51 
Age 
[Units: Years]
Mean (Full Range)
 64.4 
 (38 to 82) 
 60.5 
 (40 to 75) 
 62.5 
 (38 to 82) 
Gender 
[Units: Participants]
     
Female   9   11   20 
Male   19   12   31 
Region of Enrollment 
[Units: Participants]
     
United States   28   23   51 


  Outcome Measures

1.  Primary:   Primary Survival   [ Time Frame: Randomization to Month-2 ]

2.  Secondary:   Change in Mini–Mental State Examination (MMSE) After 2 Months   [ Time Frame: Baseline to Month-2 ]

3.  Secondary:   Barthel Score Change After 2 Months   [ Time Frame: baseline, 2 months ]

4.  Secondary:   Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months   [ Time Frame: Baseline, 2 months ]

5.  Secondary:   Change in Rankin Score After 2 Months   [ Time Frame: Baseline, 2 months ]

6.  Secondary:   ADAS-Cog Change After 2 Months Among Survivors   [ Time Frame: Baseline, 2 months ]

7.  Secondary:   Change in Phonemic Fluency (Words Beginning With Letter "D")   [ Time Frame: Baseline, 2 months ]

8.  Secondary:   Change in Semantic Verbal Fluency (Naming Animals)   [ Time Frame: Baseline, 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Geschwind, MD, PhD
Organization: UCaliforniaSF
phone: 415-476-2901
e-mail: mgeschwind@memory.ucsf.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00183092     History of Changes
Other Study ID Numbers: IA0083
P01AG021601 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2005
First Posted: September 16, 2005
Results First Submitted: January 21, 2014
Results First Posted: May 29, 2014
Last Update Posted: June 9, 2014