MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients (NCT04032626) | Clinical Trial Compass
CompletedPhase 2
MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients
United States15 participantsStarted 2020-07-22
Plain-language summary
Accumulating evidence indicates that inflammation is prominent both in the blood and central nervous system (CNS) of Alzheimer's disease (AD) patients. These data suggest that systemic inflammation plays a crucial role in the cause and effects of AD neuropathology. Capitalizing on the experience from a previous clinical trial with thalidomide, here, the investigators hypothesize that modulating both systemic and CNS inflammation via the pleiotropic immunomodulator lenalidomide is a putative therapeutic intervention for AD if administered at a proper time window during the course of the disease.
Who can participate
Age range
50 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested lenalidomide — a drug already used for certain blood cancers — in people with amnestic mild cognitive impairment related to amyloid plaques and brain inflammation; can you help me understand what the Phase 2 results showed about whether it appeared to slow cognitive decline on those specific tests like the ADAS-Cog and MMSE?
2Since this was a Phase 2 trial that has now completed, what do we know so far about the safety profile of lenalidomide when used in people with MCI, and are there any side effects from those results that would be particularly relevant to my situation?
3The trial focused specifically on amnestic MCI tied to amyloid plaques and neurodegeneration — given my diagnosis, do you think my profile actually matches the type of patient this study enrolled, and does that affect how relevant these findings are for me?
4Now that this trial is completed, is lenalidomide being studied further in a Phase 3 trial for MCI or early Alzheimer's, and would it be worth exploring whether I could participate in a follow-on study rather than waiting for results to translate into standard care?
5Compared to what this trial was investigating, are there currently approved treatments or other ongoing trials that target amyloid or brain inflammation in MCI that you think I should consider alongside or instead of waiting to see where lenalidomide research goes next?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score
Timeframe: 18 months
2
Change in cognition as assessed by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) total score
Timeframe: 18 months
3
Change in cognition as assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) total score
Timeframe: 18 months
4
Change in cognition as assessed by the Mini Mental State Examination (MMSE) total score
Timeframe: 18 months
Trial details
NCT IDNCT04032626
SponsorSt. Joseph's Hospital and Medical Center, Phoenix
. 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
. 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
. DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.
. Known history or self-reported 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 revascularization procedure/angioplasty).
. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.