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Lenalidomide for Amnestic Mild Cognitive Impairment

Recruiting

Research suggests that inflammation plays a crucial role in Alzheimer's disease. This Phase II clinical trial, referred to as MCLENA-1, will test whether lenalidomide (an anti-cancer agent) reduces inflammation and improves cognition in people with early symptomatic Alzheimer's disease (amnestic mild cognitive impairment, or aMCI).

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 89 Years All No
July 22, 2020
September 2024
30

  • Females must be surgically sterile (e.g., bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years
  • Amnestic mild cognitive impairment diagnosis according to 2011 NIA-AA guidelines
  • Mini-Mental State Exam (MMSE) score between 22-28
  • Any brain scans (CT or MRI) obtained during the course of the dementia must be consistent with the diagnosis and show no evidence of significant focal lesions or other disease that could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a brain CT scan must be obtained before starting the study
  • Vision and hearing must be strong enough to follow study procedures
  • Able to take oral medications
  • Hachinski ischemic score must be <4
  • Geriatric depression scale must be <10
  • If taking a cholinesterase inhibitor and/or memantine, the dosage must be stable for at least 90 days before joining the study and expected to remain the same for the remainder of the study period
  • Must have a study partner with significant direct contact with the participant at least 10 hours per week and who is willing to accompany the patient to all clinic visits and be present during all telephone interviews
  • If the participant has a legally authorized representative (LAR), the LAR must review and sign the informed consent form. If the participant does not have a LAR, they must be able to provide written informed consent. In addition, the patient's study partner must sign the informed consent form.
  • Must live in the community
  • Supervision must be available for the administration of all study medication
  • Participants with stable prostate cancer may be included at the discretion of the study Medical Monitor

  • Current evidence or history, within the last 3 years, of a neurological or psychiatric illness that could contribute to dementia, such as epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness
  • Meets DSM-IV diagnosis criteria for any major psychiatric disorder including psychosis, major depression, or bipolar disorder
  • Known history or suspected alcohol or substance abuse
  • Living alone
  • Poorly controlled hypertension
  • History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year, including surgery to restructure the arteries or veins such as angioplasty and vascular bypass
  • Severe pulmonary disease, including chronic obstructive pulmonary disease (COPD), requiring more than two hospitalizations within the past year
  • Requirement for home oxygen use or sleep apnea
  • Any thyroid disease (unless thyroid function is normal with treatment for at least six months prior to screening)
  • Any active conditions that cause tumor growth (except for skin tumors other than melanoma) within five years
  • History of multiple myeloma
  • Absolute neutropenia lower than normal levels of neutrophils, a type of white blood cell of less than 750/mm3, or a history of neutropenia
  • History of or current thromboembolism an obstruction of a blood vessel by a blood clot including deep venous thrombosis
  • Any clinically significant hepatic (liver) or renal (kidney) disease, including the presence of hepatitis B or C antigen/antibody or elevated transaminase levels of greater than two times the upper limit of normal (ULN) or creatinine greater than 1.5 x ULN
  • Clinically significant blood disorder, including any unexplained anemia or a platelet count less than 100,000/L at study screening
  • Use of any other clinical trial drug within 30 days or the period of time it takes for the clinical trial drug to clear the system enough to not have an effect, whichever is longer
  • Use of any clinical trial medical device within two weeks before screening for this study
  • Females who are at risk of pregnancy or are of child-bearing age
  • Unwilling or unable to undergo MRI and PET imaging
  • Cardiac pacemaker or defibrillator or other implanted device

While inflammation is common to many neurological disorders, there currently are no anti-inflammatory treatments for Alzheimer's disease. The anti-cancer agent lenalidomide is a drug that both lowers the amounts of several immune system factors that are usually high in people with Alzheimer's disease, and increases the levels of proteins that reduce inflammation.

This 18-month clinical trial will test whether lenalidomide treatment in individuals with aMCI reduces inflammation and improves cognition. Participants will receive the study drug or a placebo daily for 12 months followed by six months with no treatment. The effects of the treatment will be evaluated at 12 months and 18 months. Researchers will measure the concentration of the study drug in the blood at specified time points, as well as the drug's effects on levels of amyloid, inflammation, neurodegeneration, and cognition.

Name City State Zip Status Primary Contact
Cleveland Clinic Lou Ruvo Center for Brain health
Las Vegas Nevada 89103 Recruiting

The Cleveland Clinic

  • National Institute on Aging (NIA)

Name Role Affiliation
Marwan N Sabbagh, MD Principal Investigator The Cleveland Clinic

Name Phone Email
Marwan N Sabbagh, MD 702-483-6000 sabbagm@ccf.org

NCT04032626

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