MCLENA-2

A Phase II Clinical Trial for the Assessment of Biomarker Trajectory in Patients with
Mild Cognitive Impairment Due to Alzheimer’s Disease Treated with Lenalidomide

About the Study

This Phase II clinical trial aims to evaluate the safety and tolerability of lenalidomide, a drug currently approved by the FDA to treat cancer, in people with mild cognitive impairment (MCI) due to Alzheimer’s disease and to determine its effect on cognition, neurodegeneration, and inflammatory biomarkers in blood and cerebrospinal fluid. The study is funded by the Alzheimer’s Drug Discovery Foundation.

Who Can Participate

You may qualify for this study if:

You are between the ages of 50 and 90 (89 at the time of screening)
You have been diagnosed with MCI
You are English-speaking
You have a study partner who is willing to participate with you

Time Commitment

This study will consist of approximately 10 in-person clinic visits and four telephone visits. Participants will be in the study for up to 45 weeks, with a study treatment period of 26 weeks.

What to Expect

Not everyone will receive lenalidomide; some participants will be randomly selected for the placebo group. You will take either the drug or placebo by mouth once daily for approximately six months. In addition to providing your informed consent and medical history, you may be asked to complete the following assessments and procedures at one or more visits throughout the course of the study: