Clinical Trials/NCT01548287

NCT01548287

Completed

Phase 2

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

AstraZeneca1 site in 1 country164 target enrollmentApril 2012

ConditionsMild Cognitive Impairment Mild Alzheimer's Disease

InterventionsAZD5213 Placebo

DrugsAZD5213

Overview

Phase: Phase 2
Intervention: AZD5213
Conditions: Mild Cognitive Impairment
Sponsor: AstraZeneca
Enrollment: 164
Locations: 1
Primary Endpoint: Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

January 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient and study partner to sign informed consent before initiation of any study-related procedures.
•Clinical diagnosis of Alzheimers (AD) or mild cognitive impairment (MCI) disease.
•Single caregiver for at least 6 months prior to Screening, capable of accompanying the patient on clinic visits as needed. The caregiver must either be living with or visiting the patient at least 10 hours per week, split over multiple (at least 2) days, for the duration of the study.
•Single study partner, for at least several months prior to Screening, capable of accompanying the patient on clinic visits as needed. The study partner must either be living with or visiting the patient at least 3 days per week for the duration of the study.
•A body mass index (BMI=weight/height2) of 18 kg/m2 to 32 kg/m2.

Exclusion Criteria

•Significant neurological disease or dementia other than AD or MCI.
•Current episode or symptoms of major depressive disorder or other major psychiatric disorder.
•History of self-reported sleep duration of less than 4 hours per night or less than 4 hours average total sleep time per night during Baseline PSG assessment.
•History or present symptoms of a sleeping disorder such as sleep apnea.
•History of cancer in the last 5 years.
•Use of anti-AD drugs (including off-label drugs and herbal medications) with the exception of donepezil, memantine, and/or rivastigmine transdermal system, as monotherapy or in combination in the following conditions: treatment with donepezil (5 mg to 10 mg daily), memantine, and/or rivastigmine transdermal system or combination regimens for at least 3 months and a stable dose(s) for the last 2 months prior to randomization is allowed.

Arms & Interventions

AZD5213 doseA

AZD5213 doseA daily

Intervention: AZD5213

AZD5213 doseB

AZD 5213 doseB daily

Intervention: AZD5213

AZD5213 doseC

AZD5213 doseC daily

Intervention: AZD5213

Placebo

Placebo daily

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.

Time Frame: Baseline and Week 4.

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.

Secondary Outcomes

Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.(Baseline and Week 4.)
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.(Baseline and Week 4.)
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.(Baseline and Week 4.)
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.(Baseline and Week 4.)
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.(Baseline and Week 4.)