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 study, funded by Arizona Alzheimer’s Consortium aims to repurpose the anti-cancer drug lenalidomide and evaluate the safety of the drug in subjects with mild cognitive impairment and determine the drug’s effect on cognition, neurodegeneration, and inflammatory biomarkers in blood and cerebrospinal fluid.

Purpose

The purpose of this study is to assess the safety and tolerability of lenalidomide (an already approved FDA medication, used for a different type of patient population) in Amnestic Mild Cognitive impairment (aMCI) patients and (ii) to assess blood and Cerebrospinal Fluid (CSF) inflammatory markers after lenalidomide vs placebo administration.

Who can Participate

To be eligible for this study, subjects must meet the following inclusion criteria: 

• Male or female, at least 50 years of age, but less than 90 (89 at time of screening)
• Diagnosis of mild cognitive impairment
• English speaking
• Must be able to attend all study visits indicated in the schedule of visits
• Must have a study partner who has direct contact with the patient at least 10 hours per week and is willing to accompany the patient to specified clinic visits, supervise administration of all study medication, and be available for telephone visits/interviews

Visits

Participants completing the study will involved for up to 45 weeks in duration, from screening to end of study. The study will have 3 periods:

• Screening period (about 12 weeks)
• Study Treatment period (26 weeks)
• Follow-up period (4 weeks)

Principal Investigator

• Marwan Sabbagh, MD, FAAN