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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06263673
Other study ID # 23-008183
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 7, 2024
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Sitagliptin
100 mg once daily, oral
Dapagliflozin
10 mg once daily, oral
Placebo
Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.

Locations

Country Name City State
United States Mayo Clinic Florida Jacksonville Florida

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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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