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NCT00940589 · ClinicalTrials.gov registry record · Phase 2

Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor

A Phase 2 study, sponsored by Neurim Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
73
Enrollment target

NCT00940589: Completed Phase 2 study, sponsored by Neurim Pharmaceuticals.

NCT00940589 is a Phase 2 study that has completed, run by Neurim Pharmaceuticals. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00940589, a Phase 2 study, has completed, sponsored by Neurim Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
73 participants
Enrollment target

Study Summary

The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the decline in cognitive skills and global functioning, as well as on daytime somnolence and will be assessed.

Primary Outcome

ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a cognitive testing instrument used in clinical trials. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD. The test comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline. ADAS-cog was

Interventions

  • DRUG Placebo
  • DRUG Circadin

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2009-09
Est. Completion 2013-05
Phase Phase 2
Neurim Pharmaceuticals

6 total trials

What the finished NCT00940589 record still lists

NCT00940589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).

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

NCT00940589 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00940589 about?

NCT00940589 is a clinical study titled "Efficacy of Circadin® 2 mg in Patients With Mild to Moderate Alzheimer Disease Treated With AChE Inhibitor". The aim of this exploratory randomized, placebo controlled study is to evaluate the efficacy of Circadin® 2mg in patients with mild to moderate Alzheimer Disease (AD) treated with the acetylcholinesterase (AChE) inhibitor. The effects of add-on Circadin® 2mg vs. placebo on the decline in cognitive s...

What is the current status of trial NCT00940589?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2009-09. Estimated completion is 2013-05.

What interventions are being tested in trial NCT00940589?

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

Who is sponsoring clinical trial NCT00940589?

This trial is sponsored by Neurim Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00940589's enrollment target sits among peer trials

73 924th of 2000 higher than 1,076 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 NCT00940589, the US trial registry maintained by the National Library of Medicine. NCT00940589 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.