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NCT06996652 · ClinicalTrials.gov registry record · Phase 2

An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)

A Phase 2 study, sponsored by Yale University.

Not yet
Registry status
Phase 2
Development phase
108
Enrollment target

NCT06996652: Clinical Trial Phase 2 study, sponsored by Yale University.

NCT06996652 is a Phase 2 study that has not yet begun recruiting, run by Yale University. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06996652, a Phase 2 study, has not yet begun recruiting, sponsored by Yale University.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
108 participants
Enrollment target

Study Summary

This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.

Primary Outcome

Change from Baseline to Week 96in the expression of the Parkinson Disease Related Pattern (PDRP) assessed by 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET).

Interventions

  • DRUG Placebo
  • DRUG Adalimumab

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2026-06-29
Est. Completion 2029-08-01
Phase Phase 2
Yale University

1,492 total trials

What is known before NCT06996652 opens enrollment

NCT06996652 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT06996652 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06996652 about?

NCT06996652 is a clinical study titled "An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)". This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Di...

What is the current status of trial NCT06996652?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2026-06-29. Estimated completion is 2029-08-01.

What interventions are being tested in trial NCT06996652?

The interventions under investigation include: Placebo (DRUG), Adalimumab (DRUG).

Who is sponsoring clinical trial NCT06996652?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06996652's enrollment target sits among peer trials

108 640th of 2000 higher than 1,355 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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Source: ClinicalTrials.gov NCT06996652, the US trial registry maintained by the National Library of Medicine. NCT06996652 (mid enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.