Anti-Diabetic Medications to Fight PD and LBD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2025-01-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease

NCT02066571

Parkinson's Disease Freezing of Gait Cognitive Ability, General

UNKNOWN PHASE2

NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa

NCT05083260

Parkinson Disease

COMPLETED PHASE1/PHASE2

A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease

NCT02562768

Parkinson's Disease

COMPLETED PHASE1

A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects

NCT02604914

Parkinson's Disease

COMPLETED PHASE1

Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease

NCT00623363

Parkinson's Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lewy Body Dementia Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sitagliptin Group

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

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

100 mg once daily, oral

Dapagliflozin Group

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

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

10 mg once daily, oral

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sitagliptin

100 mg once daily, oral

Intervention Type DRUG

Dapagliflozin

10 mg once daily, oral

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DPP4 inhibitor therapy SGLT2 inhibitor therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No