MCLENA-2: A Phase II Clinical Trial for the Assessment of Lenalidomide in Patients With Mild Cognitive Impairment

Inclusion criteria

• ✓. Male or female outpatients.
• ✓. At least 50 years of age, but less than 90 (89 at time of screening)
• ✓. Females must be surgically sterile (bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years (no women at risk of pregnancy will be accepted in this study).
• ✓. Must have been diagnosed with amnestic MCI based on the most recent NIA-AA criteria (Albert et al., 2011), i.e. at both the screening and baseline visits (visits 1 and 2) have a documented Mini Mental State Exam (MMSE) score between 22-28.
• ✓. CT or MRI scan of the brain obtained during the course of the dementia must be consistent with the diagnosis and show no evidence of significant focal lesions or of pathology which could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a CT scan fulfilling the requirements must be obtained before randomization.
• ✓. Vision and hearing must be sufficient to comply with study procedures.
• ✓. Be able to take oral medications.
• ✓. Hachinski ischemic score must be ≤ 4.

Exclusion criteria