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

NCT01548287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2017-02-07

Study results available
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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.

Conditions

Interventions

DRUG

AZD5213

AZD5213 doseA daily

DRUG

AZD5213

AZD5213 doseB daily

DRUG

AZD5213

AZD5213 doseC daily

OTHER

Placebo

Placebo tablet daily

Sponsors & Collaborators

Principal Investigators

  • Robert C. Alexander, MD · AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139

  • Roza Hayduk, MD · Quintiles 10201 Wateridge Circle San Diego, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01548287 on ClinicalTrials.gov