Start: July 22, 2020
End: September 2024
What Is This Study About?
Research suggests that inflammation plays a crucial role in Alzheimer's disease. The anti-cancer drug lenalidomide 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 Phase 2 clinical trial, referred to as MCLENA-1, will test whether lenalidomide treatment in people with early symptomatic Alzheimer's disease (amnestic mild cognitive impairment) 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.
Do I Qualify To Participate in This Study?
- Females must be surgically sterile (e.g., bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for two years
- Amnestic mild cognitive impairment diagnosis according to 2011 NIA-AA guidelines
- Mini-Mental State Exam (MMSE) score between 22 and 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 be able to attend all study visits indicated in the schedule of visits
- Patients with stable prostate cancer may be included at the discretion of the Medical Monitor
- Medical records must document evidence of amnestic MCI with 1 of the following: MRI with hippocampal volume in the 5th percentile or lower for age, Amyloid PET positive at SUVr 1.05, CSF Tau profile with ATI lower than 1.0, FDG PET showing hypometabolism in the parietal temporal regions, or genetic confirmation of APOE4 (heterozygous or homozygous)
Must NOT have:
- Current evidence or history, within the last three 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
- Isolated living circumstances which would prohibit a study partner from providing sufficient and credible information about the participant
- 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, requiring more than two hospitalizations within the past year
- Untreated sleep apnea
- Any thyroid disease (unless thyroid function is normal or receiving treatment for at least six months prior to screening)
- 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
- 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 positron emission tomography imaging
- Cardiac pacemaker or defibrillator or other implanted device
- Any other disease or condition that, in the opinion of the investigator, makes the patient unsuitable to participate in this clinical trial
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Marwan N Sabbagh, M.D.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
St. Joseph's Hospital and Medical Center
Phoenix, AZ 85013
Not yet recruiting
Margeaux E Snell, MD
Cleveland Clinic Lou Ruvo Center for Brain health
Las Vegas, NV 89103
Lead: The Cleveland Clinic
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT04032626