MCLENA-1
A Phase II Clinical Trial for the Assessment of Safety, Tolerability, and Efficacy of Lenalidomide in Patients with Mild Cognitive Impairment Due to Alzheimer’s Disease” aims to evaluate the safety and tolerability of the drug lenalidomide in subjects with mild Alzheimer’s disease dementia and determine the drug’s effect on the brain and cognition
Purpose
This Phase II clinical trial aims to evaluate whether lenalidomide, a drug currently approved by the FDA to treat cancer, can improve thinking and memory skills and reduce inflammation in the brain after one year of use. The study will also assess the safety and tolerability of this drug in individuals with mild cognitive impairment (MCI) due to Alzheimer’s disease. It is funded by the National Institutes of Health (NIH).
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
Visits
This study will consist of approximately 13 clinic visits and seven telephone visits. Your study partner will be required to attend eight of the clinic visits. Each in-person visit will take approximately three to four hours. Your participation in the study will last about 78 weeks. The drug treatment period is 52 weeks, and the remaining 26 weeks will be the washout period, leading to the total 78 week duration.
