Anti-Diabetic Medications to Fight PD and LBD

Anti-Diabetic Medications to Fight Parkinson's Disease and Lewy Body Dementia

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Lewy Body Dementia
• Intervention / Treatment: Drug: Sitagliptin; Drug: Dapagliflozin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sitagliptin Group; Subjects will receive sitagliptin for the approximately 4-week treatment period.	Drug: Sitagliptin; 100 mg once daily, oral; Other Names: DPP4 inhibitor therapy
Experimental: Dapagliflozin Group; Subjects will receive dapagliflozin for the approximately 4-week treatment period.	Drug: Dapagliflozin; 10 mg once daily, oral; Other Names: SGLT2 inhibitor therapy
Placebo Comparator: Placebo Group; Subjects will receive placebo for the approximately 4-week treatment period.	Drug: Placebo; Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measures the severity and progression of Parkinson's disease. It consists of four subscales that assess various aspects of the disease, including: Non-motor experiences of daily living-Part 1 (13 questions), Motor experiences of daily living-Part 2 (13 questions), Motor examination-Part 3 (33 questions), and Motor complications-Part 4 (6 questions). Each subscale is calculated as a sum of the questions, rated from 0 (normal)-4 (severe). Thus, the subscale score ranges are: Non-motor experiences of daily living-Part 1 (range 0-52), Motor experiences of daily living-Part 2 (range 0-52), Motor examination-Part 3 (range 0-132), and Motor complication-Part 4 (range 0-24) with higher scores indicating more severe Parkinson's Disease.	Baseline, 4 weeks
Change in Mini Mental State Examination (MMSE) Score	The MMSE consists of 11 questions used by clinicians to check for cognitive impairment. Total scores range from 0 to 30 with lower scores indicating cognitive impairment.	Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Glucose	The change in fasting glucose levels (mg/dL) from baseline to 4 weeks.	Baseline, 4 weeks
Change in Orthostatic 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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jessica Wilson, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Fighting Parkinson's Disease and Lewy Body Dementia with Anti-Diabetic Medications

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Actual): January 8, 2025
• Study Completion (Actual): January 8, 2025

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Lewy Body Disease; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Pyrazines; Triazoles; Sitagliptin Phosphate; dapagliflozin
• Other Study ID Numbers: 23-008183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No