Anti-Diabetic Medications to Fight PD and LBD

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263673
• Other study ID #: 23-008183
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Lewy Body Dementia
• Lewy Body Disease
• Parkinson Disease

Intervention

Drug:
• Sitagliptin
100 mg once daily, oral
• Dapagliflozin
10 mg once daily, oral
• Placebo
Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Measures various aspects of Parkinson's disease. Score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.	Baseline, 4 weeks
Primary	Change in Mini Mental State Examination	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	Baseline, 4 weeks
Secondary	Glucose	fasting	Baseline, 4 weeks
Secondary	Supine blood pressure	Resting average for a least 10 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg	Baseline, 4 weeks
Secondary	Standing 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