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NCT01548287 · ClinicalTrials.gov registry record · Phase 2

A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
164
Enrollment target

NCT01548287: Completed Phase 2 study, sponsored by AstraZeneca.

NCT01548287 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 164 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01548287, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
164 participants
Enrollment target

Study Summary

This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.

Primary Outcome

Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.

Interventions

  • OTHER Placebo
  • DRUG AZD5213

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2012-04
Est. Completion 2013-01
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT01548287 record still lists

NCT01548287 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).

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

NCT01548287 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01548287 about?

NCT01548287 is a clinical study titled "A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment". This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.

What is the current status of trial NCT01548287?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2012-04. Estimated completion is 2013-01.

What interventions are being tested in trial NCT01548287?

The interventions under investigation include: Placebo (OTHER), AZD5213 (DRUG).

Who is sponsoring clinical trial NCT01548287?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01548287's enrollment target sits among peer trials

164 413th of 2000 higher than 1,583 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 NCT01548287, the US trial registry maintained by the National Library of Medicine. NCT01548287 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.