Anti-Diabetic Medications to Fight PD and LBD

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Lewy Body Dementia; Parkinson Disease

Treatments: Drug: Dapagliflozin; Drug: Sitagliptin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06263673

23-008183

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups, including a placebo group

Sitagliptin Group

Experimental group

Description:

Subjects will receive sitagliptin for the approximately 4-week treatment period.

Treatment:

Drug: Sitagliptin

Dapagliflozin Group

Experimental group

Description:

Subjects will receive dapagliflozin for the approximately 4-week treatment period.

Treatment:

Drug: Dapagliflozin

Placebo Group

Placebo Comparator group

Description:

Subjects will receive placebo for the approximately 4-week treatment period.

Treatment:

Drug: Placebo