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

NCT04032626 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Cognitive Impairment, Mild
  • Cognitive Dysfunction
  • Amyloid Plaque
  • Neurodegeneration
  • Inflammation, Brain

Interventions

DRUG

Lenalidomide 10 mg

Lenalid

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • The Cleveland Clinic

    collaborator OTHER

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Marwan N Sabbagh, M.D. · St. Joseph's Hospital and Medical Center, Phoenix

  • Boris Decourt, PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032626 on ClinicalTrials.gov