NCT04032626: MCLENA-1

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

Completed Phase 2 Last updated 13 June 2025

What this trial tests

Phase 2 trial testing Lenalidomide 10 mg in Cognitive Impairment, Mild in 15 participants. Completed in 31 May 2025.

Timeline

22 July 2020

Primary endpoint
31 May 2025

31 May 2025

Quick facts

Lead sponsor	St. Joseph's Hospital and Medical Center, Phoenix
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	22 July 2020
Primary completion	31 May 2025
Estimated completion	31 May 2025
Sites	2 locations across United States

Drugs / interventions tested

• Lenalidomide 10 mg — full drug profile →
• Placebo

Conditions studied

• Cognitive Impairment, Mild — all drugs for Cognitive Impairment, Mild →
• Cognitive Dysfunction — all drugs for Cognitive Dysfunction →
• Amyloid Plaque — all drugs for Amyloid Plaque →
• Neurodegeneration — all drugs for Neurodegeneration →

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Who can join

Adults 50 to 89, any sex, with Cognitive Impairment, Mild or Cognitive Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microglia in neurodegenerative diseases: mechanism and potential therapeutic targets.
   Gao C, Jiang J, Tan Y, Chen S. · · 2023 · cited 998× · PMID 37735487 · DOI 10.1038/s41392-023-01588-0
2. Alzheimer's disease drug development pipeline: 2022.
   Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
3. Alzheimer's disease drug development pipeline: 2020.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
4. Alzheimer's disease drug development pipeline: 2023.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
5. Alzheimer's disease drug development pipeline: 2021.
   Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179
6. Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
   Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970
7. Alzheimer's disease drug development pipeline: 2024.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465
8. Glial Cell-Mediated Neuroinflammation in Alzheimer's Disease.
   Al-Ghraiybah NF, Wang J, Alkhalifa AE, Roberts AB, et al · · 2022 · cited 127× · PMID 36142483 · DOI 10.3390/ijms231810572