Alzheimer's DiseasePhase 2NCT01388478
Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
A Phase 2 study testing R-pramipexole in people with Alzheimer's Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
By doing this study, researchers will examine the safety and tolerability of R-pramipexole in participants with Alzheimer's disease. This study will also examine the body and brain's response to the study drug by measuring the amount of injury to the cells (oxidative stress) in the blood and spinal fluid and brain… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- R-pramipexole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent provided by the participant or the participant's legally acceptable representative
- Age 55 years or older
- Possible/probable Alzheimer's Disease (AD)
- Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. Caregiver must visit with the subject >5 times per week.
- Rosen Modified Hachinski score of 4 or less
- Imaging Study (CT or MRI) compatible with AD or age-related changes (absence of significant abnormalities that may explain cognitive decline, such as multiple lacunar infarcts or a single prior infarct >1 cubic cm, microhemorrhages or evidence of a prior hemorrhage > 1 cubic cm, evidence of cerebral contusion encephalomalacia, aneurysm, vascular malformation, or space occupying lesion such as an arachnoid cyst or brain tumor).
- Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments
Who cannot join
- Significant neurological disease, other than AD, that may affect cognition
- Current clinically-significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.
- History of clinically-evident stroke
- Clinically-significant infection within the last 30 days
- Myocardial infarction or symptoms of active coronary artery disease (e.g., angina) in the last two years.
- Uncontrolled hypertension within the last 6 months.
Show all 10Show fewer
- History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
- History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
- Insulin dependent diabetes mellitus
- Significant pain or musculoskeletal disorder that would prohibit participation in metabolic testing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Safety/Tolerability and Effects on Cognitive Impairment, Impaired Cerebral Cortical Metabolism and Oxidative Stress of R(+)Pramipexole Administered to Subjects With Early Alzheimer's Disease
By doing this study, researchers will examine the safety and tolerability of R-pramipexole in participants with Alzheimer's disease. This study will also examine the body and brain's response to the study drug by measuring the amount of injury to the cells (oxidative stress) in the blood and spinal fluid and brain imaging before and after treatment.
Read the detailed description
Subjects will be recruited from the Univ of Kansas Alzheimer's Center and will provide informed consent about participating.
R(+)-pramipexole will be provided as Good Manufacturing Practice powder and taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with Dr. Burns prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
Primary Outcome Measure:
1.Number of Patients with Adverse Events [Time Frame: Every 2 months] [Safety Issue: Yes]
Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.
Secondary Outcome Measures:
Reduction of Oxidative Stress [Time Frame: Baseline and at 24 weeks after taking study drug] [Safety Issue: No]
A lumbar puncture (spinal tap) will be performed to collect cerebral spinal fluid, which will be assayed for isoprostane levels before and after treatment.
Changes in cerebral glucose metabolism [Time Frame: Baseline and at 24 weeks after taking drug] [Safety Issue: No]
Positron Emission Tomography 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-fluorodeoxyglucose.
Effects on Cognitive Performance [Time Frame: Baseline and then 6 months thereafter] [Safety Issue: Yes]
Quantitative assessment of cognitive status will be taken at baseline and at end of 6 month dosing period.
- Conditions
- Alzheimer's Disease
- Being tested
- R-pramipexole
- Keywords
- Safety, Tolerability, R(+)Pramipexole, Alzheimer's
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-pramipexoleDrug
Also called Dexpramipexole
R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
| Study group | Role | What they receive |
|---|---|---|
| R(+)pramipexole | Experimental | Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm. Receives: Drug: R-pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events
Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas, Alzheimer's Drug Discovery Foundation
- Responsible party
- Sponsor
- Investigators
- James P. Bennett, MD, PhD, Principal investigator, Virginia Commonwealth UniversityJeffrey M Burns, MD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388478
- Sponsor's protocol ID
- VCU-KU-ADDF-2011
- Other IDs
- 20101202
- Status last verified
- Sep 2021
- First submitted
- 30 Jun 2011
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety/Tolerability and Effects on Cognitive Impairment, Impaired Cerebral Cortical Metabolism and Oxidative Stress of R(+)Pramipexole Administered to Subjects With Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01388478
- Acronym / sponsor ID
- VCU-KU-ADDF-2011
- Conditions
- Alzheimer's Disease
- Keywords
- Safety, Tolerability, R(+)Pramipexole, Alzheimer's
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- University of Kansas, Alzheimer's Drug Discovery Foundation
- Study start
- Jul 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By doing this study, researchers will examine the safety and tolerability of R-pramipexole in participants with Alzheimer's disease. This study will also examine the body and brain's response to the study drug by measuring the amount of injury to the cells (oxidative stress) in the blood and spinal fluid and brain imaging before and after treatment.
Detailed description
Subjects will be recruited from the Univ of Kansas Alzheimer's Center and will provide informed consent about participating.
R(+)-pramipexole will be provided as Good Manufacturing Practice powder and taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with Dr. Burns prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
Primary Outcome Measure:
1.Number of Patients with Adverse Events [Time Frame: Every 2 months] [Safety Issue: Yes]
Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.
Secondary Outcome Measures:
Reduction of Oxidative Stress [Time Frame: Baseline and at 24 weeks after taking study drug] [Safety Issue: No]
A lumbar puncture (spinal tap) will be performed to collect cerebral spinal fluid, which will be assayed for isoprostane levels before and after treatment.
Changes in cerebral glucose metabolism [Time Frame: Baseline and at 24 weeks after taking drug] [Safety Issue: No]
Positron Emission Tomography 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-fluorodeoxyglucose.
Effects on Cognitive Performance [Time Frame: Baseline and then 6 months thereafter] [Safety Issue: Yes]
Quantitative assessment of cognitive status will be taken at baseline and at end of 6 month dosing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R(+)pramipexole | Experimental | Drug: R-pramipexoleEach study participant will be given the active study drug, R-pramipexole. There is no placebo arm. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent provided by the participant or the participant's legally acceptable representative
- Age 55 years or older
- Possible/probable Alzheimer's Disease (AD)
- Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. Caregiver must visit with the subject >5 times per week.
- Rosen Modified Hachinski score of 4 or less
Key exclusion criteria (10 listed)
- Significant neurological disease, other than AD, that may affect cognition
- Current clinically-significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.
- History of clinically-evident stroke
- Clinically-significant infection within the last 30 days
- Myocardial infarction or symptoms of active coronary artery disease (e.g., angina) in the last two years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-pramipexoleAlso: DexpramipexoleR-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects. | Drug | R(+)pramipexole |
Primary outcome
Number of Patients With Adverse Events
Time frame: 6 months
Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P. Bennett, MD, PhD principal investigator
Virginia Commonwealth University
Jeffrey M Burns, MD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-pramipexole in people with Alzheimer's Disease, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.