Trial results for dapagliflozin in patients with Parkinson Disease and Lewy Body Dementia were posted on ClinicalTrials.gov on 2026-01-28. The Phase 4 study, which also included sitagliptin, investigated the neurological effects of anti-diabetic medications. Key analyses showed statistically significant differences between the intervention groups for "MDS-UPDRS score-part 1" (p-value: 0.008) and "MDS-UPDRS score-part 2" (p-value: 0.02).
Background
The study, titled "Anti-Diabetic Medications to Fight PD and LBD," aimed to test the hypothesis that DPP4 inhibitors (like sitagliptin) and SGLT2 inhibitors (like dapagliflozin) are well tolerated and have beneficial neurological effects for Parkinson's disease and Lewy body dementia. Dapagliflozin is an SGLT2 inhibitor, a class of drugs primarily used for type 2 diabetes, heart failure, and chronic kidney disease.
Trial design
The Phase 4 study (NCT06263673) was completed with an enrollment of 18 participants. It investigated interventions including sitagliptin, dapagliflozin, and placebo in individuals with Lewy Body Dementia and Parkinson Disease. The study did not list specific primary outcome measures.
Key results
The trial measured the "Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score." The median changes observed for the various groups across different parts of the scale were:
- For "MDS-UPDRS score-part 1": Sitagliptin Group median change was 3.0; Dapagliflozin Group median change was -2.5; Placebo Group median change was -2.5.
- For "MDS-UPDRS score-part 2": Sitagliptin Group median change was 1.5; Dapagliflozin Group median change was -3.0; Placebo Group median change was -0.5.
- For "MDS-UPDRS score-part 3": Sitagliptin Group median change was -2.0; Dapagliflozin Group median change was -3.0; Placebo Group median change was 0.0.
- For "MDS-UPDRS score-part 4": Sitagliptin Group median change was 0.0; Dapagliflozin Group median change was 0.0; Placebo Group median change was 0.0.
Statistical analyses using ANOVA revealed the following p-values for differences between groups:
- "MDS-UPDRS score-part 1": p-value: 0.008
- "MDS-UPDRS score-part 2": p-value: 0.02
- "MDS-UPDRS score-part 3": p-value: 0.19
- "MDS-UPDRS score-part 4": p-value: 0.33
Additional ANOVA analyses not specified by MDS-UPDRS part showed p-values of 0.67 and 0.65.
What this means
The statistically significant p-values for "MDS-UPDRS score-part 1" (0.008) and "MDS-UPDRS score-part 2" (0.02) suggest that there were overall differences in these specific components of the Parkinson's Disease rating scale among the sitagliptin, dapagliflozin, and placebo groups. While the median changes for dapagliflozin showed some reductions in MDS-UPDRS scores, the small sample size of 18 participants and the presence of similar or greater reductions in the placebo group for certain parts, along with the involvement of sitagliptin in the overall group comparison, mean that specific conclusions about dapagliflozin's individual efficacy against placebo for these conditions cannot be definitively drawn from this data alone. These results may warrant further investigation in larger trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06263673, titled "Anti-Diabetic Medications to Fight PD and LBD," were posted on 2026-01-28 on clinicaltrials.gov.