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

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

Treatments tested in this trial

  • Empagliflozin
  • Insulin
  • Insulin Placebo
  • Empagliflozin Placebo

Treatment groups

30 Participants
are divided into 3 treatment groups