MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients

Eligibility Criteria

• * In order to be eligible for this study, subjects must meet the following
• * Subjects will be excluded if they have any of the condition listed below:
• 1. Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, head injury with loss of consciousness
• 2. DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.
• 3. Known history or self-reported alcohol or substance abuse.
• 4. Isolated living circumstances which would prohibit a study partner from providing sufficient and credible information about the participant.
• 5. Poorly controlled hypertension.
• 6. History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure/angioplasty).
• 7. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.
• 8. Untreated sleep apnea.
• 9. Any thyroid disease (unless euthyroid or on treatment for at least 6 months prior to screening).
• 10. Active neoplastic disease (except for skin tumors other than melanoma). Patients with a history of prior malignancy are eligible provided they were treated with curative intent and (i) do not require any longer any active therapy; (ii) being considered in complete remission; and (iii) after the Medical Monitor's assessment/approval of each case.
• 11. History of multiple myeloma.
• 12. Absolute neutropenia of \<750mm3, or history of neutropenia.
• 13. History of or current thromboembolism (including deep venous thrombosis).
• 14. Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C antigen/antibody or an elevated transaminase levels of greater than two times the upper limit of normal (ULN) or creatinine greater than 1.5 x ULN).
• 15. Clinically significant hematologic or coagulation disorder including any unexplained anemia or a platelet count less than 100,000/μL at screening.
• 16. Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer.
• 17. Use any investigational medical device within two weeks before screening or after end of the present study.
• 18. Females who are at risk of pregnancy or are of child bearing age.
• 19. Any other disease or condition that, in the opinion of the investigator, makes the patient unsuitable to participate in this clinical trial.
• 20. Unwilling or unable to undergo MRI and PET imaging.
• 21. Cardiac pacemaker or defibrillator or other implanted device.
• 22. In the opinion of the Investigator, participation would not be in the best interest of the subject.