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MCLENA-2: A Phase II Clinical Trial for the Assessment of Lenalidomide in Patients With Mild Cognitive Impairment

NCT06177028 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-05-18

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, parallel group study. The use of placebo is appropriate to minimize bias related to treatment expectations of the subject, study partner, and site investigator, as well as to changes in the relationship between the subject and study partner that might occur with the initiation of treatment and expectation of improvement in motor symptoms or cognition. Changes in subject/study partner interactions can impact subject mood and might introduce biases that cannot be quantified. The double-blind use of placebo will also prevent bias in the clinical and scientific assessments.

Conditions

  • Cognitive Impairment, Mild
  • Cognitive Dysfunction
  • Amyloid Plaque
  • Neurodegenerative Disease, Hereditary
  • Inflammation, Brain

Interventions

DRUG

Lenalidomide 10 mg

Lenalidomide is a cancer drug, It is also known by it's brand name Revlimid.

Sponsors & Collaborators

  • Texas Tech University

    collaborator OTHER

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-01-02
Completion
2027-01-02
FDA Drug
Yes

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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 NCT06177028 on ClinicalTrials.gov