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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Survival | Randomization to Month-2 | Participants alive after 2 months on study treatment |
| Secondary | Change in Mini-Mental State Examination (MMSE) After 2 Months | Baseline 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. |
| Secondary | Barthel Score Change After 2 Months | baseline, 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. |
| Secondary | Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months | Baseline, 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. |
| Secondary | Change in Rankin Score After 2 Months | Baseline, 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. |
| Secondary | ADAS-Cog Change After 2 Months Among Survivors | Baseline, 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. |
| Secondary | Change 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. |
| Secondary | Change 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Survival | Randomization to Month-2 | participants | NUMBER | |
| SECONDARY | Change in Mini-Mental State Examination (MMSE) After 2 Months | Baseline 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 scale | MEAN |
| SECONDARY | Barthel Score Change After 2 Months | baseline, 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 scale | MEAN |
| SECONDARY | Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months | Baseline, 2 months | For subjects still alive at month 2 and assessed at the 2-month visit or via telephone | units on a scale | MEAN |
| SECONDARY | Change in Rankin Score After 2 Months | Baseline, 2 months | For subjects still alive at month 2 and assessed at the 2-month visit or via telephone | units on a scale | MEAN |
| SECONDARY | ADAS-Cog Change After 2 Months Among Survivors | Baseline, 2 months | Subjects still alive and able to tolerate cognitive testing at Month 2 visit. | units on a scale | MEAN |
| SECONDARY | Change in Phonemic Fluency (Words Beginning With Letter D) | Baseline, 2 months | Subject still alive and able to tolerate cognitive testing at month 2 visit | number of words generated | MEAN |
| SECONDARY | Change in Semantic Verbal Fluency (Naming Animals) | Baseline, 2 months | Subjects still alive and able to tolerate cognitive testing at month 2 visit. | number of words generated | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Survival | Placebo | 19 | participants | ||
| Primary Survival | Quinacrine | 13 | participants | ||
| Change in Mini-Mental State Examination (MMSE) After 2 Months | Placebo | -6.9 | Full Range -18 to 4 | units on a scale | |
| Change in Mini-Mental State Examination (MMSE) After 2 Months | Quinacrine | -3.9 | Full Range -10 to 1 | units on a scale | |
| Barthel Score Change After 2 Months | Placebo | -23.2 | Full Range -85 to 70 | units on a scale | |
| Barthel Score Change After 2 Months | Quinacrine | -13.2 | Full Range -65 to 5 | units on a scale | |
| Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months | Placebo | 3.2 | Full Range -1 to 8 | units on a scale | |
| Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months | Quinacrine | 0.3 | Full Range -1 to 2 | units on a scale | |
| Change in Rankin Score After 2 Months | Placebo | 0.8 | Full Range 0 to 2 | units on a scale | |
| Change in Rankin Score After 2 Months | Quinacrine | 0.3 | Full Range -1 to 2 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind (Baseline - Month 2) | STARTED | Quinacrine | 23 | |
| Double-blind (Baseline - Month 2) | STARTED | Placebo | 28 | |
| Double-blind (Baseline - Month 2) | STARTED | Study Drug (Quinacrine) During Open-Label Period | 0 | |
| Double-blind (Baseline - Month 2) | STARTED | Study Drug (Placebo) During Open-Label Period | 0 | |
| Double-blind (Baseline - Month 2) | Alive at Month 2 | Quinacrine | 13 | |
| Double-blind (Baseline - Month 2) | Alive at Month 2 | Placebo | 19 | |
| Double-blind (Baseline - Month 2) | Alive at Month 2 | Study Drug (Quinacrine) During Open-Label Period | 0 | |
| Double-blind (Baseline - Month 2) | Alive at Month 2 | Study Drug (Placebo) During Open-Label Period | 0 | |
| Double-blind (Baseline - Month 2) | Came in for Month 2 Visit | Quinacrine | 10 | |
| Double-blind (Baseline - Month 2) | Came in for Month 2 Visit | Placebo | 16 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events90
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal abscess | Gastrointestinal disorders | Placebo Random Assignment | 0 | 28 | |
| other | Abdominal abscess | Gastrointestinal disorders | Quinacrine Random Assignment | 1 | 23 | |
| other | Abdominal abscess | Gastrointestinal disorders | Quinacrine Open-label | 0 | 24 | |
| other | Agitation | Psychiatric disorders | Placebo Random Assignment | 1 | 28 | |
| other | Agitation | Psychiatric disorders | Quinacrine Random Assignment | 2 | 23 | |
| other | Agitation | Psychiatric disorders | Quinacrine Open-label | 2 | 24 | |
| other | Elevated Liver Function Tests | Hepatobiliary disorders | Placebo Random Assignment | 0 | 28 | |
| other | Elevated Liver Function Tests | Hepatobiliary disorders | Quinacrine Random Assignment | 3 | 23 | |
| other | Elevated Liver Function Tests | Hepatobiliary disorders | Quinacrine Open-label | 12 | 24 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo Random Assignment | 1 | 28 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Random Assignment | ||
| Total, all-cause mortality | Quinacrine Random Assignment | ||
| Total, all-cause mortality | Quinacrine Open-label | ||
| Total, other adverse events | Placebo Random Assignment | 9 | 28 |
| Total, other adverse events | Quinacrine Random Assignment | 9 | 23 |
| Total, other adverse events | Quinacrine Open-label | 16 | 24 |
| Total, serious adverse events | Placebo Random Assignment | 14 | 28 |
| Total, serious adverse events | Quinacrine Random Assignment | 13 | 23 |
| Total, serious adverse events | Quinacrine Open-label | 14 | 24 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P01AG021601 | Novel Therapeutics for Prion Diseases | PRUSINER, STANLEY B | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE ON AGING | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Quinacrine vs Placebo: Primary Survival |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Fluency | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
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