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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin Group | Experimental | Subjects will receive sitagliptin for the approximately 4-week treatment period. |
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| Dapagliflozin Group | Experimental | Subjects will receive dapagliflozin for the approximately 4-week treatment period. |
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| Placebo Group | Placebo Comparator | Subjects will receive placebo for the approximately 4-week treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | 100 mg once daily, oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Glucose | The change in fasting glucose levels (mg/dL) from baseline to 4 weeks. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Wilson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42318251 | Derived | 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. |
| Label | URL |
|---|---|
| Fighting Parkinson's Disease and Lewy Body Dementia with Anti-Diabetic Medications | View source |
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5 subjects screen failed prior to randomization assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin Group | Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral |
| FG001 | Dapagliflozin Group | Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral |
| FG002 | Placebo Group | Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin Group | Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral |
| BG001 | Dapagliflozin Group | Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | score on a scale | Baseline, 4 weeks |
|
Adverse events were collected from the time of informed consent through study completion, approximately 4 weeks.
Adverse event definition used for this study: An untoward or undesirable experience associated with the use of a medical product (i.e. drug, device, biologic) in a patient or research subject.
At each contact with the subject, the study team sought information on adverse events by specific questioning and if needed, by examination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin Group | Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Wilson, M.D. | Mayo Clinic | 904-953-2392 | Wilson.Jessica3@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2023 | Nov 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C529054 | dapagliflozin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dapagliflozin | Drug | 10 mg once daily, oral |
|
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| Placebo | Drug | Once daily, oral. Looks similar to the study drug, but it contains no active ingredient. |
|
| Baseline, 4 weeks |
| BG002 | Placebo Group | Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Subjects received sitagliptin for the approximately 4-week treatment period. Sitagliptin: 100 mg once daily, oral |
| OG001 | Dapagliflozin Group | Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral |
| OG002 | Placebo Group | Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient. |
|
|
|
| Primary | 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. | Posted | Median | Full Range | score on a scale | Baseline, 4 weeks |
|
|
|
|
| Secondary | Change in Fasting Glucose | The change in fasting glucose levels (mg/dL) from baseline to 4 weeks. | Posted | Median | Full Range | mg/dL | Baseline, 4 weeks |
|
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|
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| Secondary | 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 | Posted | Median | Full Range | mmHg | Baseline, 4 weeks |
|
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|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Dapagliflozin Group | Subjects received dapagliflozin for the approximately 4-week treatment period. Dapagliflozin: 10 mg once daily, oral | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Placebo Group | Subjects received placebo for the approximately 4-week treatment period. Placebo: Once daily, oral. Looks similar to the study drug, but it contains no active ingredient. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011719 |
| Pyrazines |
|
| 0.91 |
| Superiority |