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| ID | Type | Description | Link |
|---|---|---|---|
| 20101202 | Other Grant/Funding Number | Alzheimer's Drug Discovery Foundation |
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| Name | Class |
|---|---|
| University of Kansas | OTHER |
| Alzheimer's Drug Discovery Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R(+)pramipexole | Experimental | Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-pramipexole | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Effects on Cognitive Performance | Quantitative assessment of cognitive status will be taken at baseline and at end of 6 month dosing period. | Baseline and then 6 months thereafter |
| Changes in Cerebral Glucose Metabolism |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James P. Bennett, MD, PhD | Virginia Commonwealth University | Principal Investigator |
| Jeffrey M Burns, MD | University of Kansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | R(+)Pramipexole | Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm. R-pramipexole: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | R(+)Pramipexole | Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm. R-pramipexole: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R(+)Pramipexole | Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm. R-pramipexole: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation/irritability | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Burns, M.D., M.S. | University of Kansas Medical Center | 913-588-0555 | KUAMP@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2011 | Aug 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000097662 | Dexpramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
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.
| Baseline and at 24 weeks after taking drug |
| Reduction of Oxidative Stress | A lumbar puncture (spinal tap) will be performed to collect cerebral spinal fluid, which will be assayed for isoprostane levels before and after treatment. | Baseline and at 24 weeks after taking study drug |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Other Pre-specified | Effects on Cognitive Performance | Quantitative assessment of cognitive status will be taken at baseline and at end of 6 month dosing period. | Not Posted | Baseline and then 6 months thereafter | Participants |
| Other Pre-specified | Changes in Cerebral Glucose Metabolism | 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. | Not Posted | Baseline and at 24 weeks after taking drug | Participants |
| Other Pre-specified | Reduction of Oxidative Stress | A lumbar puncture (spinal tap) will be performed to collect cerebral spinal fluid, which will be assayed for isoprostane levels before and after treatment. | Not Posted | Baseline and at 24 weeks after taking study drug | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 18 |
| 20 |
| Tooth problems | General disorders | Non-systematic Assessment |
|
| Chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cold symptoms | Infections and infestations | Non-systematic Assessment |
|
| Confabulations | Nervous system disorders | Non-systematic Assessment |
|
| Contusion | Nervous system disorders | Non-systematic Assessment |
|
| Coughing | General disorders | Non-systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dreaming | Psychiatric disorders | Non-systematic Assessment |
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| Falls | Nervous system disorders | Non-systematic Assessment |
|
| Hallucinations | Nervous system disorders | Non-systematic Assessment |
|
| Increased confusion | Nervous system disorders | Non-systematic Assessment |
|
| Increased depression | Psychiatric disorders | Non-systematic Assessment |
|
| Increased libido | Endocrine disorders | Non-systematic Assessment |
|
| Injury to urethra | Renal and urinary disorders | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Laceration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Nausea or vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Sensation in throat | General disorders | Non-systematic Assessment |
|
| Sinus issues | General disorders | Non-systematic Assessment |
|
| Sleep disturbance | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Sweating | General disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Weight loss | General disorders | Non-systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |