Health Trials

Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease

ConditionAlzheimer Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fluent in English

Diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease via previously documented clinical assessment

Amyloid positive by PET or cerebrospinal fluid criteria

Stable medical condition for 3 months prior to screening visit

Disqualifiers

A diagnosis of dementia other than Alzheimer's disease

History of a clinically significant stroke, history of transient ischemic attack within 12 months, or any history of seizures

Current evidence or history in past two years of head injury with loss of consciousness, any major psychiatric disorder including psychosis, unstable major depressive disorder, bipolar disorder

Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin

    Drug

    empagliflozin 10 mg every day

  • Insulin

    Drug

    Intranasal insulin 40 international units four times daily

  • Insulin Placebo

    Drug

    matching placebo for intranasal insulin

  • Empagliflozin Placebo

    Drug

    matching placebo for empagliflozin

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Insulin and Empagliflozin Matching PlaceboExperimental treatment 2 interventions
Group B: Empagliflozin and Insulin Matching PlaceboExperimental treatment 2 interventions
Group C: Double PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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.

Time frame
baseline and month 6

Other outcomes

1

Change in Alzheimer's disease biomarkers

number of participants with change in Alzheimer's disease biomarkers

Time frame
from baseline to month 6
2

change in hippocampal volume

change in hippocampal assessed with MRI

Time frame
from baseline to month 6
3

change in meta-ROI volume

change in meta-ROI volumes assessed with MRI

Time frame
from baseline to month 6
4

Change in Amyloid-Related Imaging Abnormalities (ARIA)

number of participants with ARIA

Time frame
from baseline to month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: