Lewy Body DementiaPhase 4NCT06263673
Anti-Diabetic Medications to Fight PD and LBD
A Phase 4 study testing Sitagliptin and Dapagliflozin in people with Lewy Body Dementia and Parkinson Disease, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Lewy Body Dementia, Parkinson Disease
- What is being tested?
- Sitagliptin and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2024to 8 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Anti-Diabetic Medications to Fight Parkinson's Disease and Lewy Body Dementia
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
- Being tested
- Sitagliptin, Dapagliflozin, Placebo
- Medical subject headings
- Lewy Body Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called DPP4 inhibitor therapy
100 mg once daily, oral
DapagliflozinDrug
Also called SGLT2 inhibitor therapy
10 mg once daily, oral
PlaceboDrug
Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin Group | Experimental | Subjects will receive sitagliptin for the approximately 4-week treatment period. Receives: Drug: Sitagliptin |
| Dapagliflozin Group | Experimental | Subjects will receive dapagliflozin for the approximately 4-week treatment period. Receives: Drug: Dapagliflozin |
| Placebo Group | Placebo comparator | Subjects will receive placebo for the approximately 4-week treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 4 weeks
Secondary outcomes (2)
Change in Fasting Glucose
The change in fasting glucose levels (mg/dL) from baseline to 4 weeks.
Measured: Baseline, 4 weeks
Change in Orthostatic Blood Pressure
Standing average for 15 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start7 May 2024
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lewy Body DementiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica R. Wilson, Mayo Clinic
- Investigators
- Jessica Wilson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263673
- Sponsor's protocol ID
- 23-008183
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2024
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chmiela T, Dulski J, Heckman MG, Fang ZJ, Wszolek ZK, Wilson JR. Anti-diabetic medications to fight Parkinson's disease and dementia with Lewy bodies: a pilot study. Front Neurol. 2026 May 29;17:1825229. doi: 10.3389/fneur.2026.1825229. eCollection 2026.
PubMed 42318251
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Diabetic Medications to Fight Parkinson's Disease and Lewy Body Dementia
- ClinicalTrials.gov ID
- NCT06263673
- Acronym / sponsor ID
- 23-008183
- Conditions
- Lewy Body Dementia, Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin Group | Experimental | Drug: SitagliptinSubjects will receive sitagliptin for the approximately 4-week treatment period. |
| Dapagliflozin Group | Experimental | Drug: DapagliflozinSubjects will receive dapagliflozin for the approximately 4-week treatment period. |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects will receive placebo for the approximately 4-week treatment period. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinAlso: DPP4 inhibitor therapy100 mg once daily, oral | Drug | Sitagliptin Group |
| DapagliflozinAlso: SGLT2 inhibitor therapy10 mg once daily, oral | Drug | Dapagliflozin Group |
| PlaceboOnce daily, oral. Looks similar to the study drug, but it contains no active ingredient. | Drug | Placebo Group |
Primary outcome
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score
Time frame: Baseline, 4 weeks
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.
Change in Mini Mental State Examination (MMSE) Score
Time frame: Baseline, 4 weeks
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.
2 secondary outcomes
Change in Fasting Glucose
Time frame: Baseline, 4 weeks
Change in Orthostatic Blood Pressure
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42318251Chmiela T, Dulski J, Heckman MG, Fang ZJ, Wszolek ZK, Wilson JR. Anti-diabetic medications to fight Parkinson's disease and dementia with Lewy bodies: a pilot study. Front Neurol. 2026 May 29;17:1825229. doi: 10.3389/fneur.2026.1825229. eCollection 2026.
- Fighting Parkinson's Disease and Lewy Body Dementia with Anti-Diabetic MedicationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Wilson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin and Dapagliflozin in people with Lewy Body Dementia and Parkinson Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score (time frame: Baseline, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.