Anti-Diabetic Medications to Fight PD and LBD

Phase 4

Active, not recruiting

• Conditions: Lewy Body Dementia; Parkinson Disease
• Interventions: Drug: Placebo; Drug: Sitagliptin; Drug: Dapagliflozin

• Registration Number: NCT06263673
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-16
• Study Start: 2024-05-07
• Status Verified: 2024-08
• Primary Completion: 2025-01-08
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Subjects will receive placebo for the approximately 4-week treatment period.
Sitagliptin Group	Sitagliptin	Subjects will receive sitagliptin for the approximately 4-week treatment period.
Dapagliflozin Group	Dapagliflozin	Subjects will receive dapagliflozin for the approximately 4-week treatment period.

Primary Outcome Measures

Name	Time	Method
Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Baseline, 4 weeks	Measures various aspects of Parkinson's disease. Score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Change in Mini Mental State Examination	Baseline, 4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Glucose	Baseline, 4 weeks	fasting
Supine blood pressure	Baseline, 4 weeks	Resting average for a least 10 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg
Standing blood pressure	Baseline, 4 weeks	Standing average for 15 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States