Trial · NCT01388478
Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
NCT01388478, Phase 2, Completed, Virginia Commonwealth University; results first posted 2021-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease. Trials, record NCT01388478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01388478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
- NCT number
- NCT01388478
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Alzheimer's Disease
- Interventions
- R-pramipexole
- First posted
- 2011-07-06
- Last updated
- 2021-10-12
- Results first posted
- 2021-10-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Adverse Events | 6 months | Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events. |
| Other | Effects on Cognitive Performance | Baseline and then 6 months thereafter | Quantitative assessment of cognitive status will be taken at baseline and at end of 6 month dosing period. |
| Other | Changes in Cerebral Glucose Metabolism | Baseline and at 24 weeks after taking drug | PET Scan will be performed. Changes in cerebral glucose metabolism as a proxy for mitochondrial respiration will be assayed at baseline and 24 weeks. Correlations will be sought with assays of oxidative stress reduction to see if greater reductions in brain oxidative stress are reflected in elevations of cortical 2-FDG. |
| Other | Reduction of Oxidative Stress | Baseline and at 24 weeks after taking study drug | A lumbar puncture (spinal tap) will be performed to collect cerebral spinal fluid, which will be assayed for isoprostane levels before and after treatment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Adverse Events | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Effects on Cognitive Performance | Baseline and then 6 months thereafter | |||
| OTHER_PRE_SPECIFIED | Changes in Cerebral Glucose Metabolism | Baseline and at 24 weeks after taking drug | |||
| OTHER_PRE_SPECIFIED | Reduction of Oxidative Stress | Baseline and at 24 weeks after taking study drug |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events | R(+)Pramipexole | 18 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | R(+)Pramipexole | 20 | |
| Overall Study | COMPLETED | R(+)Pramipexole | 15 | |
| Overall Study | NOT COMPLETED | R(+)Pramipexole | 5 |
Source ClinicalTrials.gov
Adverse events29
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 | Agitation/irritability | Psychiatric disorders | R(+)Pramipexole | 2 | 20 | 2 |
| other | Tooth problems | General disorders | R(+)Pramipexole | 2 | 20 | 2 |
| other | Chest pain | Musculoskeletal and connective tissue disorders | R(+)Pramipexole | 1 | 20 | 1 |
| other | Cold symptoms | Infections and infestations | R(+)Pramipexole | 1 | 20 | 1 |
| other | Confabulations | Nervous system disorders | R(+)Pramipexole | 1 | 20 | 1 |
| other | Contusion | Nervous system disorders | R(+)Pramipexole | 2 | 20 | 2 |
| other | Coughing | General disorders | R(+)Pramipexole | 1 | 20 | 1 |
| other | Decreased appetite | Gastrointestinal disorders | R(+)Pramipexole | 1 | 20 | 1 |
| other | Dizziness | Nervous system disorders | R(+)Pramipexole | 2 | 20 | 2 |
| other | Dreaming | Psychiatric disorders | R(+)Pramipexole | 2 | 20 | 2 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | R(+)Pramipexole | 0 | 20 |
| Total, other adverse events | R(+)Pramipexole | 18 | 20 |
| Total, serious adverse events | R(+)Pramipexole | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT01388478
GET https://conductscience.org/api/trials/v1/NCT01388478/events?page=2