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NCT04032626 · ClinicalTrials.gov registry record · Phase 2
MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients
A Phase 2 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT04032626: Completed Phase 2 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT04032626 is a Phase 2 study that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04032626, a Phase 2 study, has completed, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
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.
Primary Outcome
To evaluate the effect on cognition Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) of lenalidomide 10 mg/kg titrated for up to 12 months and washed out for 6 months. ADAS is 70 points. A lower score is better
Interventions
- DRUG Placebo
- DRUG Lenalidomide 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2025-05-31 |
| Phase | Phase 2 |
What the finished NCT04032626 record still lists
NCT04032626 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04032626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04032626 about?
NCT04032626 is a clinical study titled "MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients". 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 fro...
What is the current status of trial NCT04032626?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2020-07-22. Estimated completion is 2025-05-31.
What interventions are being tested in trial NCT04032626?
The interventions under investigation include: Placebo (DRUG), Lenalidomide 10 mg (DRUG).
Who is sponsoring clinical trial NCT04032626?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04032626's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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