Lewy Body Dementia, Parkinson Disease
Conditions
Brief 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.
Interventions
DRUGSitagliptin
100 mg once daily, oral
DRUGDapagliflozin
10 mg once daily, oral
DRUGPlacebo
Once daily, oral. Looks similar to the study drug, but it contains no active ingredient.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Glucose | Baseline, 4 weeks | The change in fasting glucose levels (mg/dL) from baseline to 4 weeks. |
| Change in Orthostatic Blood Pressure | Baseline, 4 weeks | Standing average for 15 minutes of three blood pressures collected by an automated oscillometric device (blood pressure cuff) reported in mm Hg |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Wilson, MD
Mayo Clinic
Participant flow
Pre-assignment details
5 subjects screen failed prior to randomization assignment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 5 |
Outcome results
None listed