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Trial · NCT00183092

CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

NCT00183092, Phase 2, Completed, University of California, San Francisco; results first posted 2014-05-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. CJD (Creutzfeldt-Jakob Disease) Quinacrine Study. Trials, record NCT00183092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00183092

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
CJD (Creutzfeldt-Jakob Disease) Quinacrine Study
NCT number
NCT00183092
Status
Completed
Phases
Phase 2
Enrollment
69 participants, actual
Lead sponsor
University of California, San Francisco
Conditions
Creutzfeldt-Jakob Disease
Interventions
Quinacrine, Placebo
First posted
2005-09-16
Last updated
2014-06-09
Results first posted
2014-05-29

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPrimary SurvivalRandomization to Month-2Participants alive after 2 months on study treatment
SecondaryChange in Mini-Mental State Examination (MMSE) After 2 MonthsBaseline to Month-2
The mini-mental state examination (MMSE) is a brief 30-point questionnaire that is used to screen for cognitive impairment. In about 10 minutes it samples functions including arithmetic, memory and orientation. A score greater than or equal to 25 points (out of 30) indicates a normal cognition. Lower scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment. Low to very low scores correlate closely with the presence of dementia, although other mental disorders can also lead to abnormal findings on MMSE testing.
SecondaryBarthel Score Change After 2 Monthsbaseline, 2 months
An ordinal scale used to measure performance in activities of daily living. Scores range from 0 (worst, fully dependent) to 100 (best, independent); higher score associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. 10 individual items are scored and summed to derive the overall Barthel index score. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The amount of time and physical assistance required to perform each item are considered in scoring each item. For subjects unable to return for month-2 visit, Barthel Index was performed via telephone.
SecondaryChange in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 MonthsBaseline, 2 months
Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB). The CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The global CDR score is computed via an algorithm. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. A higher value and/or positive change is worse. For subjects unable to return for month-2 visit, CDRS-SB was performed via telephone.
SecondaryChange in Rankin Score After 2 MonthsBaseline, 2 months
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. For subjects unable to return for the 2-month visit, Rankin score was assessed via telephone.
SecondaryADAS-Cog Change After 2 Months Among SurvivorsBaseline, 2 months
ADAS-cog measures cognitive performance by combining ratings of 11 components (word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering instruction, spoken language, word finding, comprehension) representing six areas of cognition: memory; language; orientation to time, place and person; construction of simple designs and planning; and performing simple behaviors in pursuit of a basic, predefined goal. Seven components are scored as the 'number incorrect'. For example, in the commands component, the number of five commands performed incorrectly (range: 0-5). Four components are scored from 0 (no limitations) to 5 (max limitations) as the examiner's perception of remembering instructions, spoken language ability, word finding and comprehension. Component scores are summed into a total ADAS-cog score ranging from 0-75, with low scores indicating better cognitive performance.
SecondaryChange in Phonemic Fluency (Words Beginning With Letter "D")Baseline, 2 months
Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (words beginning with letter "D") is phonemic. Higher scores indicate better cognition.
SecondaryChange in Semantic Verbal Fluency (Naming Animals)Baseline, 2 months
Verbal fluency tests are a kind of psychological test in which participants have to say as many words as possible from a category in 60 seconds. This category (naming animals) is semantic. Higher scores indicate better cognition.

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPrimary SurvivalRandomization to Month-2participantsNUMBER
SECONDARYChange in Mini-Mental State Examination (MMSE) After 2 MonthsBaseline to Month-2
Subjects still alive, who attended the month-2 visit and were willing and able to tolerate cognitive testing. 1 subject in each arm did attend the 2-month visit but did not cooperate fully with the MMSE, which was therefore not scored.
units on a scaleMEAN
SECONDARYBarthel Score Change After 2 Monthsbaseline, 2 months
One surviving subject in the quinacrine arm did not attend the 2-month visit and was lost-to-followup; for a second surviving subject in the quinacrine arm, the Barthel Index was inadvertently not performed at the 2-month visit.
units on a scaleMEAN
SECONDARYChange in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 MonthsBaseline, 2 monthsFor subjects still alive at month 2 and assessed at the 2-month visit or via telephoneunits on a scaleMEAN
SECONDARYChange in Rankin Score After 2 MonthsBaseline, 2 monthsFor subjects still alive at month 2 and assessed at the 2-month visit or via telephoneunits on a scaleMEAN
SECONDARYADAS-Cog Change After 2 Months Among SurvivorsBaseline, 2 monthsSubjects still alive and able to tolerate cognitive testing at Month 2 visit.units on a scaleMEAN
SECONDARYChange in Phonemic Fluency (Words Beginning With Letter D)Baseline, 2 monthsSubject still alive and able to tolerate cognitive testing at month 2 visitnumber of words generatedMEAN
SECONDARYChange in Semantic Verbal Fluency (Naming Animals)Baseline, 2 monthsSubjects still alive and able to tolerate cognitive testing at month 2 visit.number of words generatedMEAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Primary SurvivalPlacebo19participants
Primary SurvivalQuinacrine13participants
Change in Mini-Mental State Examination (MMSE) After 2 MonthsPlacebo-6.9Full Range -18 to 4units on a scale
Change in Mini-Mental State Examination (MMSE) After 2 MonthsQuinacrine-3.9Full Range -10 to 1units on a scale
Barthel Score Change After 2 MonthsPlacebo-23.2Full Range -85 to 70units on a scale
Barthel Score Change After 2 MonthsQuinacrine-13.2Full Range -65 to 5units on a scale
Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 MonthsPlacebo3.2Full Range -1 to 8units on a scale
Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 MonthsQuinacrine0.3Full Range -1 to 2units on a scale
Change in Rankin Score After 2 MonthsPlacebo0.8Full Range 0 to 2units on a scale
Change in Rankin Score After 2 MonthsQuinacrine0.3Full Range -1 to 2units on a scale

Participant flow32

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Double-blind (Baseline - Month 2)STARTEDQuinacrine23
Double-blind (Baseline - Month 2)STARTEDPlacebo28
Double-blind (Baseline - Month 2)STARTEDStudy Drug (Quinacrine) During Open-Label Period0
Double-blind (Baseline - Month 2)STARTEDStudy Drug (Placebo) During Open-Label Period0
Double-blind (Baseline - Month 2)Alive at Month 2Quinacrine13
Double-blind (Baseline - Month 2)Alive at Month 2Placebo19
Double-blind (Baseline - Month 2)Alive at Month 2Study Drug (Quinacrine) During Open-Label Period0
Double-blind (Baseline - Month 2)Alive at Month 2Study Drug (Placebo) During Open-Label Period0
Double-blind (Baseline - Month 2)Came in for Month 2 VisitQuinacrine10
Double-blind (Baseline - Month 2)Came in for Month 2 VisitPlacebo16

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAbdominal abscessGastrointestinal disordersPlacebo Random Assignment028
otherAbdominal abscessGastrointestinal disordersQuinacrine Random Assignment123
otherAbdominal abscessGastrointestinal disordersQuinacrine Open-label024
otherAgitationPsychiatric disordersPlacebo Random Assignment128
otherAgitationPsychiatric disordersQuinacrine Random Assignment223
otherAgitationPsychiatric disordersQuinacrine Open-label224
otherElevated Liver Function TestsHepatobiliary disordersPlacebo Random Assignment028
otherElevated Liver Function TestsHepatobiliary disordersQuinacrine Random Assignment323
otherElevated Liver Function TestsHepatobiliary disordersQuinacrine Open-label1224
otherDiarrheaGastrointestinal disordersPlacebo Random Assignment128

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo Random Assignment
Total, all-cause mortalityQuinacrine Random Assignment
Total, all-cause mortalityQuinacrine Open-label
Total, other adverse eventsPlacebo Random Assignment928
Total, other adverse eventsQuinacrine Random Assignment923
Total, other adverse eventsQuinacrine Open-label1624
Total, serious adverse eventsPlacebo Random Assignment1428
Total, serious adverse eventsQuinacrine Random Assignment1323
Total, serious adverse eventsQuinacrine Open-label1424

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
5952734BACKGROUNDPubMed
9811807BACKGROUNDPubMed
10787002BACKGROUNDPubMed
11504948BACKGROUNDPubMed
12666126BACKGROUNDPubMed
24122181DERIVEDPubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P01AG021601Novel Therapeutics for Prion DiseasesPRUSINER, STANLEY BUNIVERSITY OF CALIFORNIA, SAN FRANCISCONATIONAL INSTITUTE ON AGING2003 to 2013

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Quinacrine vs Placebo: Primary Survival

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed as
Verbal FluencySecondary outcome

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00183092

GET https://conductscience.org/api/trials/v1/NCT00183092/flow?page=2