Parkinson Disease Clinical Trial
Official title:
Anti-Diabetic Medications to Fight Parkinson's Disease and Lewy Body Dementia
Verified date | May 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test the hypothesis that DPP4 inhibitors and SGLT2 inhibitors are well tolerated and have beneficial neurological effects, specifically for Parkinson's disease and Lewy body dementia.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 65 Years |
Eligibility | Inclusion Criteria: - Parkinson's disease or Lewy Body Dementia (diagnosis confirmed by neurologist at Mayo Clinic) with stable neurological treatment in the past approximately three months. - Glucose intolerance or mild diabetes: The American Diabetes Association criteria for pre-diabetes/ glucose intolerance includes fasting glucose 100-125, random glucose 140-199, or hemoglobin A1C 5.7-6.4% and diabetes is > 125 mg/dL, > 200 mg/dL, and 6.5% or greater, respectively (40). It has been previously reported that 50-80% of individuals with Parkinson's disease have abnormal glucose tolerance (17), so this should not limit recruitment. Exclusion Criteria: - Use of insulin or other anti-diabetes medications other than metformin. - Contraindication to taking a DPP4 inhibitor or SGLT2 inhibitor including: allergy, history of angioedema, pancreatitis, active gallbladder disease, renal impairment with EGFR < 45). - Bleeding disorder, use of anticoagulants, thrombocytopenia, or severe anemia. - Use of high dose steroids. - Current systemic chemotherapy. - Pregnancy or breastfeeding. - Recent (within 30 days) or recurrent (defined as more than one in the past 12 months) urinary tract infection or yeast infection. - Other contraindication that would make study participation unsafe or make study related data unable to be interpreted. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Measures various aspects of Parkinson's disease. Score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. | Baseline, 4 weeks | |
Primary | Change in Mini Mental State Examination | Set of 11 questions used by clinicians to check for cognitive impairment. Scoring 30-25 indicates normal and below 24 is abnormal indicating possible cognitive impairment | Baseline, 4 weeks | |
Secondary | Glucose | fasting | Baseline, 4 weeks | |
Secondary | Supine blood pressure | Resting average for a least 10 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg | Baseline, 4 weeks | |
Secondary | Standing blood pressure | Standing average for 15 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg | Baseline, 4 weeks |
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