← Trials/Trial dossier/NCT06263673

CompletedPhase 4Results posted

Anti-Diabetic Medications to Fight PD and LBD

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

Lead sponsor

Mayo Clinic

Assets

Dapagliflozin / Sitagliptin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Lewy body dementia

Key I/E criterion

•Age 45-65

Primary endpoints

•Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)•Mini-Mental State Examination (MMSE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID23-008183

NCT IDNCT06263673

Timeline

Milestones

Study first posted2024-02-16actual

Study start2024-05-07actual

Primary completion2025-01-08actual

Study completion2025-01-08actual

Last update posted2026-01-28actual

Results first posted2026-01-28actual

Assets

Drug assets

Dapagliflozin Sitagliptin

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age45 Years

Maximum age65 Years

SexAll

Healthy volunteersNot 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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Other clinical outcomes

Global cognition

2 endpoints

Primary/protocol endpoint

Change in Mini Mental State Examination (MMSE) Score

Time frame:Baseline, 4 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change in Mini Mental State Examination (MMSE) Score

Time frame:Baseline, 4 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (median), score on a scale	Reported bounds
Sitagliptin Groupn=4 Participants	1.5	-0.0 - 4.0
Dapagliflozin Groupn=4 Participants	0.5	--2.0 - 3.0
Placebo Groupn=4 Participants	1.5	--1.0 - 3.0

p0.67ANOVA

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Change in Orthostatic Blood Pressure

Time frame:Baseline, 4 weeks

change from baseline, improvement

Secondary/registry result

Change in Orthostatic Blood Pressure

Time frame:Baseline, 4 weeks

change from baseline, improvement

Posted result

Group	Value (median), mmHg	Reported bounds
Sitagliptin GroupSystolic Blood Pressuren=4 Participants	-0.1	--2.0 - 11.2
Diastolic Blood Pressuren=4 Participants	-4.6	--11.2 - 12.0
Dapagliflozin GroupSystolic Blood Pressuren=4 Participants	3.4	--6.4 - 18.2
Diastolic Blood Pressuren=4 Participants	0.0	--14.0 - 3.8
Placebo GroupSystolic Blood Pressuren=4 Participants	4.8	--44.0 - 12.0
Diastolic Blood Pressuren=4 Participants	5.2	--21.0 - 13.4

p0.67ANOVA

Systolic Blood Pressure

p0.91ANOVA

Diastolic Blood Pressure

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Baseline, 4 weeks

change from baseline, improvement

Primary/registry result/low confidence

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

Time frame:Baseline, 4 weeks

change from baseline, improvement

Posted result

Group	Value (median), score on a scale	Reported bounds
Sitagliptin GroupMDS-UPDRS score-part 1n=4 Participants	3.0	-1.0 - 4.0
MDS-UPDRS score-part 2n=4 Participants	1.5	-0.0 - 4.0
MDS-UPDRS score-part 3n=4 Participants	-2.0	--6.0 - 0.0
MDS-UPDRS score-part 4n=4 Participants	0.0	-0.0 - 8.0
Dapagliflozin GroupMDS-UPDRS score-part 1n=4 Participants	-2.5	--7.0 - 0.0
MDS-UPDRS score-part 2n=4 Participants	-3.0	--4.0 - 0.0
MDS-UPDRS score-part 3n=4 Participants	-3.0	--14.0 - 0.0
MDS-UPDRS score-part 4n=4 Participants	0.0	--4.0 - 1.0
Placebo GroupMDS-UPDRS score-part 1n=4 Participants	-2.5	--4.0 - -1.0
MDS-UPDRS score-part 2n=4 Participants	-0.5	--3.0 - 1.0
MDS-UPDRS score-part 3n=4 Participants	0.0	-0.0 - 2.0
MDS-UPDRS score-part 4n=4 Participants	0.0	--2.0 - 0.0

p0.008ANOVA

MDS-UPDRS score-part 1

p0.020ANOVA

MDS-UPDRS score-part 2

p0.19ANOVA

MDS-UPDRS score-part 3

p0.33ANOVA

MDS-UPDRS score-part 4

Secondary/protocol endpoint/low confidence

Change in Fasting Glucose

Time frame:Baseline, 4 weeks

change from baseline, improvement

Secondary/registry result/low confidence

Change in Fasting Glucose

Time frame:Baseline, 4 weeks

change from baseline, improvement

Posted result

Group	Value (median), mg/dL	Reported bounds
Sitagliptin Groupn=4 Participants	-3.5	--73.0 - 2.0
Dapagliflozin Groupn=4 Participants	-1.0	--29.0 - 8.0
Placebo Groupn=4 Participants	-5.0	--24.0 - 15.0

p0.65ANOVA

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID42318251via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.