Anti-Diabetic Medications to Fight PD and LBD

NCT06263673 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 23-008183
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lewy Body Dementia; Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Fasting Glucose

  Baseline, 4 weeks

• Change in Orthostatic Blood Pressure

  Baseline, 4 weeks

Study Arms (3)

Sitagliptin Group

EXPERIMENTAL

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

Drug: Sitagliptin

Dapagliflozin Group

EXPERIMENTAL

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

Drug: Dapagliflozin

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sitagliptin DRUG

100 mg once daily, oral

Also known as: DPP4 inhibitor therapy

Sitagliptin Group

Dapagliflozin DRUG

10 mg once daily, oral

Also known as: SGLT2 inhibitor therapy

Dapagliflozin Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

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

MeSH Terms

Conditions

Lewy Body Disease; Parkinson Disease

Interventions

Sitagliptin Phosphate; dapagliflozin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Jessica Wilson, M.D.
• Organization: Mayo Clinic

Wilson.Jessica3@mayo.edu

904-953-2392

Study Officials

• Jessica Wilson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: May 7, 2024
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)