Fighting Parkinson’s Disease and Lewy Body Dementia with Anti-Diabetic Medications to

Overview

About this study

The purpose of this study is to test the hypotheses that genetically reduced DPP4 and SGLT2 (loss of function variants of genes DPP4 and SLC5A2) confer metabolic and neurological benefit. Also, to test the hypothesis that prospective intervention with a DPP4 inhibitor or SGLT2 inhibitor improves Parkinson’s disease and Lewy Body Dementia related biomarkers compared to placebo.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults age 45 years and older.
  • 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/23/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jessica Wilson, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
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CLS-20563911

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