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

Primary Purpose

Mild Cognitive Impairment, Mild Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD5213
AZD5213
AZD5213
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Mild Alzheimer's disease, Safety, Tolerability

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AZD5213 doseA

AZD5213 doseB

AZD5213 doseC

Placebo

Arm Description

AZD5213 doseA daily

AZD 5213 doseB daily

AZD5213 doseC daily

Placebo daily

Outcomes

Primary Outcome Measures

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

Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.
Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.
Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.
Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.
Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data

Full Information

First Posted
March 5, 2012
Last Updated
December 14, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01548287
Brief Title
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Mild Alzheimer's Disease
Keywords
Mild Cognitive Impairment, Mild Alzheimer's disease, Safety, Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD5213 doseA
Arm Type
Experimental
Arm Description
AZD5213 doseA daily
Arm Title
AZD5213 doseB
Arm Type
Experimental
Arm Description
AZD 5213 doseB daily
Arm Title
AZD5213 doseC
Arm Type
Experimental
Arm Description
AZD5213 doseC daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily
Intervention Type
Drug
Intervention Name(s)
AZD5213
Intervention Description
AZD5213 doseA daily
Intervention Type
Drug
Intervention Name(s)
AZD5213
Intervention Description
AZD5213 doseB daily
Intervention Type
Drug
Intervention Name(s)
AZD5213
Intervention Description
AZD5213 doseC daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet daily
Primary Outcome Measure Information:
Title
Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
Description
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.
Time Frame
Baseline and Week 4.
Secondary Outcome Measure Information:
Title
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.
Time Frame
Baseline and Week 4.
Title
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.
Time Frame
Baseline and Week 4.
Title
Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.
Description
Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data
Time Frame
Baseline and Week 4.
Title
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.
Description
Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Time Frame
Baseline and Week 4.
Title
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.
Description
Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Time Frame
Baseline and Week 4.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C. Alexander, MD
Organizational Affiliation
AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roza Hayduk, MD
Organizational Affiliation
Quintiles 10201 Wateridge Circle San Diego, CA
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Indio
State/Province
California
Country
United States
Facility Name
Research Site
City
Lomita
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Delray Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Hallandale Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Eatontown
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33189083
Citation
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1316&filename=D3030C00005_Clinical_Study_Report_Synopsis.pdf
Description
D3030C00005_Clinical_Study_Report_Synopsis.pdf

Learn more about this trial

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

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