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Completed

NCT Number: NCT06263673

Anti-Diabetic Medications to Fight PD and LBD

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.

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Key information

Conditions

Lewy Body Dementia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitagliptin

Drug

100 mg once daily, oral

Other names: DPP4 inhibitor therapy

Dapagliflozin

Drug

10 mg once daily, oral

Other names: SGLT2 inhibitor therapy

Placebo

Drug

Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.

Primary outcomes

  1. Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score

    Time frame: Baseline, 4 weeks

    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.

  2. Change in Mini Mental State Examination (MMSE) Score

    Time frame: Baseline, 4 weeks

    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.

Secondary outcomes

  1. Change in Fasting Glucose

    Time frame: Baseline, 4 weeks

    The change in fasting glucose levels (mg/dL) from baseline to 4 weeks.

  2. Change in Orthostatic Blood Pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 16, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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