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Anti-Diabetic Medications

Dapagliflozin Group for Dementia

Phase 4

Recruiting

Led By Jessica Wilson, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks

Awards & highlights

Study Summary

This trial aims to see if certain medications are safe and helpful for patients with Parkinson's disease and Lewy body dementia.

Who is the study for?

This trial is for individuals with Parkinson's disease or Lewy body dementia. Specific criteria for joining are not provided, but typically participants must meet certain health standards and may be required to have a specific stage of the diseases.Check my eligibility

What is being tested?

The study is testing two types of diabetes medications, Sitagliptin (a DPP4 inhibitor) and Dapagliflozin (an SGLT2 inhibitor), against a placebo to see if they can help with neurological symptoms in Parkinson's disease and Lewy body dementia.See study design

What are the potential side effects?

While side effects are not listed here, common ones for Sitagliptin include sore throat, upper respiratory infection, headache and diarrhea; for Dapagliflozin they might include genital infections, increased urination, and potential risk of dehydration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Mini Mental State Examination

Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Secondary outcome measures

Glucose

Standing blood pressure

Supine blood pressure

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Sitagliptin GroupExperimental Treatment1 Intervention

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

Group II: Dapagliflozin GroupExperimental Treatment1 Intervention

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

Group III: Placebo GroupPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dapagliflozin

2014

Completed Phase 4

~64440

Sitagliptin

2011

Completed Phase 4

~10170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,476 Total Patients Enrolled

25 Trials studying Dementia

17,085 Patients Enrolled for Dementia

Jessica Wilson, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted approval for the use of Dapagliflozin Group?

"Our team at Power has rated the safety of Dapagliflozin Group as a 3 on our scale, given that this trial falls under Phase 4 indicating an already approved treatment."

Answered by AI

Is the research study including individuals younger than 40 years of age?

"Individuals aged between 45 and 65 are eligible for enrollment in this study. Notably, there is a limited number of clinical trials available for individuals under the age of 18 (35 trials) and those who are over 65 years old (899 trials)."

Answered by AI

Are new participants currently being welcomed to enroll in this trial?

"Per information on clinicaltrials.gov, recruitment for this trial is currently closed. The study was initially listed on February 12th, 2024, with the latest update made on February 9th, 2024. Although enrollment is not ongoing for this specific trial, there are presently 905 other trials seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anti-Diabetic Medications to Fight PD and LBD

Jessica R. Wilson 2024. "Anti-Diabetic Medications to Fight PD and LBD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263673.

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