MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amyloid Plaque
- Cognitive Dysfunction
- Cognitive Impairment, Mild
- Inflammation, Brain
- Neurodegeneration
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study will take place at a single site. We will enroll 30 male and female outpatients, 50-90 years of age. Lenalidomide 10 mg/day vs. placebo will be taken daily orally (ratio 1:1). The effects of lenalidomide treatment will be assessed after 12 months of treatment and 6 months washout (month 18). Participants completing the study will be involved for up to 20 months in duration, from screening to end of study.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Beside the clinical pharmacologist and biostatistician, all parties involved in the present study will be blinded until all data are collected, including medical staff, patients and his/her car giver, imaging staff, and scientists collecting data from biosamples. The blinding will be lifted only after all data are acquired, and before statistical analysis.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 89 years
- Gender
- Both males and females
Description
There are currently no approved treatments to treat the neuroinflammatory aspects of AD. While inflammation is pervasive to many neurological disorders, no clinical trial has yet demonstrated the efficacy of anti-inflammatory agents for AD. Interestingly, chronic peripheral low-grade inflammation is...
There are currently no approved treatments to treat the neuroinflammatory aspects of AD. While inflammation is pervasive to many neurological disorders, no clinical trial has yet demonstrated the efficacy of anti-inflammatory agents for AD. Interestingly, chronic peripheral low-grade inflammation is associated with aging and increases the risk for disease and mortality, including AD. Accumulating evidence indicates that nuclear factor-kappa B, tumor necrosis factor alpha (TNF?), interleukins (e.g. IL-1beta, IL-2, and IL-6), and chemokines (e.g. IL-8) are found elevated both in the blood and central nervous system (CNS) of AD patients. These data confirm that inflammation plays a central role in the cause and effect of AD neuropathology. The immunomodulator, anti-cancer agent lenalidomide is one of the very few pleiotropic agents that both lowers the expression of TNF?, IL-6, IL-8, and increases the expression of anti-inflammatory cytokines (e.g. IL-10), to modulate both innate and adaptive immune responses. In the current project the investigators aim to test the central hypothesis that lenalidomide reduces inflammatory and AD-associated pathological biomarkers, and improves cognition. For this, the investigators designed an 18-month, Phase II, double-blind, randomized, two-armed, parallel group, placebo controlled, and proof-of-mechanism clinical study in early symptomatic AD subjects (i.e. amnestic mild cognitive impairment; aMCI). The effects of lenalidomide treatment will be assessed after 12 months of treatment and 6 months washout (month 18).
Tracking Information
- NCT #
- NCT04032626
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Principal Investigator: Marwan N Sabbagh, M.D. The Cleveland Clinic
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