The purpose of this study is to find out what effects (good and bad) the study medications (insulin or Empagliflozin) have on adults with mild memory impairment or early Alzheimer's disease who are clinically prescribed an anti-amyloid therapy compared to placebo.
The proposed pilot study will evaluate the efficacy, safety and tolerability of two therapeutic approaches: treatment with intranasal insulin in combination with anti-amyloid targeting therapy (ATT) and treatment with the sodium-glucose cotransporter type 2 inhibitor empagliflozin in combination with ATT, to correct bioenergetic and vascular dysfunction in adults with mild cognitive impairment due to Alzheimer's disease or mild dementia due to Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
empagliflozin 10 mg every day
Intranasal insulin 40 international units four times daily
matching placebo for intranasal insulin
Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging
Winston-Salem, North Carolina, United States
Number of treatment-related serious adverse events
Number of treatment related serious adverse events experienced by participants during course of study
Time frame: Month 6
Alzheimer's Disease Assessment Scale-Cognition Score
The Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-Cog 14) is an evaluation of cognitive impairment in Alzheimer's disease including 14 different sub-tests that can be summed for a total score of 0-90. Higher scores indicate more severe cognitive impairment in Alzheimer's disease.
Time frame: baseline and month 6
Modified Preclinical Alzheimer Cognitive Composite 5 Score
The modified Pre-clinical Alzheimer's Cognitive Composite (MPACC5) is a composite of several different cognitive measures designed to assess cognitive functioning in early Alzheimer's disease. Average Z scores will be calculated as baseline and post-intervention Z scores will be calculated using the baseline group mean and standard deviation. Total score range is -3 to 3. Negative z-scores reflect lower than expected cognitive functioning, positive z-scores reflect higher than expected cognitive functioning.
Time frame: baseline and month 6
Montreal Cognitive Assessment Score
Montreal Cognitive Assessment (MoCA) is measure of global cognitive functioning used to detect cognitive impairment. It includes several sub-sections assessing various cognitive domains that are summed for a total score of 0-30. Higher scores indicate more intact cognitive functioning, lower scores indicate the presence of cognitive impairment.
Time frame: baseline and month 6
Clinical Dementia Rating Scale Score
The Clinical Dementia Rating Scale measures dementia severity based on an interview with the patient and a caregiver. Scores ranging from 0 to 18 with higher scores indicating a higher severity of dementia.
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matching placebo for empagliflozin
Time frame: baseline and month 6