NCT01548287

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

A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients With Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Placebo-Controlled

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Designed as a Randomized, Double-Blind, Multi-Center, Parallel Group, Placebo-Controlled Study

Conditions

• Mild Cognitive Impairment
• Mild Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	AZD5213	AZD5213 doseA daily
DRUG	AZD5213	AZD5213 doseB daily
DRUG	AZD5213	AZD5213 doseC daily
OTHER	Placebo	Placebo tablet daily

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-03-08
• Last updated: 2017-02-07
• Results posted: 2016-12-05

Locations

13 sites across 1 country: United States