NCT01548287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

December 5, 2016

Completed
Last Updated

February 7, 2017

Status Verified

December 1, 2016

Enrollment Period

9 months

First QC Date

March 5, 2012

Results QC Date

January 26, 2015

Last Update Submit

December 14, 2016

Conditions

Mild Cognitive ImpairmentMild Alzheimer's Disease

Keywords

Mild Cognitive ImpairmentMild Alzheimer's diseaseSafetyTolerability

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and Week 4.

Secondary Outcomes (5)

  • 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 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 Actigraphy Recording.

    Baseline and Week 4.

Study Arms (4)

AZD5213 doseA

EXPERIMENTAL

AZD5213 doseA daily

Drug: AZD5213

AZD5213 doseB

EXPERIMENTAL

AZD 5213 doseB daily

Drug: AZD5213

AZD5213 doseC

EXPERIMENTAL

AZD5213 doseC daily

Drug: AZD5213

Placebo

PLACEBO COMPARATOR

Placebo daily

Other: Placebo

Interventions

AZD5213DRUG

AZD5213 doseA daily

AZD5213 doseA
PlaceboOTHER

Placebo tablet daily

Placebo

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Phoenix, Arizona, United States

Location

Research Site

Indio, California, United States

Location

Research Site

Lomita, California, United States

Location

Research Site

San Francisco, California, United States

Location

Research Site

Delray Beach, Florida, United States

Location

Research Site

Fort Myers, Florida, United States

Location

Research Site

Hallandale, Florida, United States

Location

Research Site

Orlando, Florida, United States

Location

Research Site

Tampa, Florida, United States

Location

Research Site

Eatontown, New Jersey, United States

Location

Research Site

Brooklyn, New York, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Related Publications (1)

  • 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.

    PMID: 33189083DERIVED

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Joel Posener, MD
Organization
AstraZeneca Pharmaceuticals LP, Neuroscience iMed
clinicaltrialtransparency@astrazeneca.net

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 7, 2017

Results First Posted

December 5, 2016

Record last verified: 2016-12

Locations

US(13)