Restoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in Alzheimer's Disease
REstoring Vascular and Insulin Function To Augment Anti-Amyloid Therapy in ALZheimer'ss Disease (REVITAA-ALZ): A Placebo-controlled Trial of Intranasal Insulin vs. Empagliflozin in Mild Cognitive Impairment (MCI) or Early Alzheimer's Disease (AD) Treated With Anti-Amyloid Targeting Therapy (Lecanemab or Donanemab)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the good and bad effects of insulin or empagliflozin compared with a placebo, which has no active medicine. It is for adults with mild memory problems due to Alzheimer's disease or mild Alzheimer's who are already receiving treatment that targets amyloid, a protein that builds up in the brain.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Speak English fluently.
- Have a documented diagnosis of mild memory and thinking problems due to Alzheimer's disease or mild Alzheimer's.
- Have a PET scan or spinal fluid test showing amyloid.
- Have a stable medical condition for 3 months before screening.
- Have stable doses of general medicines for 4 weeks before screening and study visits, unless the study doctor allows an exception.
- Have been stable on lecanemab or donanemab for at least 8 weeks before the starting visit. If taking donepezil, rivastigmine, galantamine, or memantine, have a stable dose for at least 30 days.
- Have normal lab results, or results the study doctor judges are not a medical concern.
- Have a study partner who takes part throughout the study, has about 10 hours of contact each week, and can report on your thinking and daily skills.
Who can't join
- Have dementia other than Alzheimer's, a significant past stroke, a mini-stroke in the past 12 months, or any past seizures.
- Have a current or recent history, within 2 years, of a head injury with loss of consciousness or a major mental health disorder, including psychosis, unstable major depression, or bipolar disorder.
- Have type 1 or type 2 diabetes, or regularly used insulin or another diabetes medicine within 2 months before screening.
- Had cancer within 2 years, except non-melanoma skin cancer or prostate cancer that has not spread and has been stable for at least 6 months. Are pregnant or possibly pregnant.
- Take blood thinners that prevent clots, have a poorly controlled bleeding disorder, or have a history of an immune system disease or treatment with medicines that suppress or change the immune system.
- Live in a skilled nursing facility, or used an experimental treatment within 2 months before screening.
- Regularly use alcohol, narcotics, seizure medicines, Parkinson's medicines, or other medicines not allowed by the study. The study doctor may allow some exceptions.
- Cannot safely have an MRI scan, including because of fear of tight spaces or certain metal implants or pacemakers. Certain starting MRI findings also rule out joining, including brain bleeding, swelling, strokes, severe tissue changes, abnormal blood vessels, infection, tumors, or other major brain problems.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 * Stable medications for general medical conditions for 4 weeks prior to the screening and study visits (exceptions may be made on a case-by-case basis by study clinician) * Stable on Anti-Amyloid Targeting Therapy (lecanemab or donanemab) for at least 8 weeks prior to Baseline Visit * If receiving an acetylcholinesterase inhibitor (donepezil, rivastigmine, galantamine) or memantine or both, must be stable on a dose for at least 30 days prior to Baseline Visit * Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study clinician * Participants must have a study partner who agrees to participate throughout the duration of the study. The study partner must have frequent and sufficient contact (approximately 10 hours per week) with the participant and be able to provide accurate information regarding the participant's cognitive and functional abilities. Exclusion Criteria: * 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 * Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit * Cancer within the past 2 years with the exception of non-melanoma skin cancers and non-metastatic prostate cancer that has been stable for at least 6 months * Pregnancy or possible pregnancy * Use of anticoagulants * Residence in a skilled nursing facility at screening * Use of an investigational agent within two months of screening visit * Regular use of alcohol, narcotics, anticonvulsants, anti-Parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case-by-case basis by study clinician) * Any history of immunologic disease (e.g. lupus, rheumatoid arthritis, Crohn's disease) or systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives * History of a bleeding disorder that is not under adequate control, including a platelet count less than 50,000 or INR greater than 1.5 * Contraindications for MRI, including claustrophobia or the presence of contraindicated metal implants/cardiac pacemaker * Baseline MRI Findings: More than four microhemorrhages defined as 10mm or less at the greatest diameter; A single macro hemorrhage greater than 10mm at greatest diameter; An area of superficial siderosis; Evidence of vasogenic edema; More than two lacunar infarcts or stroke involving a major vascular territory; Severe subcortical hyperintensities consistent with Fazekas score of 3; Evidence of amyloid beta-related angiitis (ABRA); Cerebral amyloid angiopathy (CAA); Cerebral contusion, encephalomalacia, brain aneurysm or other vascular malformations, central nervous system infection, brain tumor, or other major intracranial pathology that may cause cognitive impairment
Study sites (1)
NC
- Wake Forest Alzheimer's Disease Research Center (ADRC) Sticht Center for Healthy Aging · Winston-Salem, NC 27157Suzanne Craft, PhD · Study contact · 336-716-6463 · mindadrcahwfb@advocatehealth.orgMore trials in Winston-Salem