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

December 14, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • Indio, California, United States
        • Research Site
      • Lomita, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
    • Florida
      • Delray Beach, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Hallandale Beach, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
    • New Jersey
      • Eatontown, New Jersey, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AZD5213 doseA
AZD5213 doseA daily
Drug: AZD5213
AZD5213 doseA daily
Drug: AZD5213
AZD5213 doseB daily
Drug: AZD5213
AZD5213 doseC daily
EXPERIMENTAL: AZD5213 doseB
AZD 5213 doseB daily
Drug: AZD5213
AZD5213 doseA daily
Drug: AZD5213
AZD5213 doseB daily
Drug: AZD5213
AZD5213 doseC daily
EXPERIMENTAL: AZD5213 doseC
AZD5213 doseC daily
Drug: AZD5213
AZD5213 doseA daily
Drug: AZD5213
AZD5213 doseB daily
Drug: AZD5213
AZD5213 doseC daily
PLACEBO_COMPARATOR: Placebo
Placebo daily
Other: Placebo
Placebo tablet daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 4.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Robert C. Alexander, MD, AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139
  • Study Director: Roza Hayduk, MD, Quintiles 10201 Wateridge Circle San Diego, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (ESTIMATE)

March 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2017

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3030C00005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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