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CompletedNCT01548287Updated Feb 7, 2017Results posted

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

A Phase 2 interventional study of AZD5213 and AZD5213 in Mild Cognitive Impairment and Mild Alzheimer's Disease, sponsored by AstraZeneca. Completed at 13 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-02-07.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Mild Cognitive Impairment
  • Mild Alzheimer's Disease

Keywords

  • Mild Cognitive Impairment
  • Mild Alzheimer's disease
  • Safety
  • Tolerability
03

In context

Cognitive Dysfunction

3,932 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's enrollment of 164 is above the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 265 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    AZD5213 doseA

    AZD5213 doseA daily

    Drug: AZD5213

  • Experimental
    AZD5213 doseB

    AZD 5213 doseB daily

    Drug: AZD5213

  • Experimental
    AZD5213 doseC

    AZD5213 doseC daily

    Drug: AZD5213

  • Placebo comparator
    Placebo

    Placebo daily

    Other: Placebo

Interventions

  • DrugAZD5213

    AZD5213 doseA daily

  • DrugAZD5213

    AZD5213 doseB daily

  • DrugAZD5213

    AZD5213 doseC daily

  • OtherPlacebo

    Placebo tablet daily

06

What researchers measure

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.

    Time frame: Baseline and Week 4.

Secondary outcomes

  1. Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.

    Time frame: Baseline and Week 4.

  2. Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.

    Time frame: Baseline and Week 4.

  3. 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

    Time frame: Baseline and Week 4.

  4. 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

    Time frame: Baseline and Week 4.

  5. 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

    Time frame: Baseline and Week 4.

07

Results

Posted Dec 5, 2016

Participant flow

Screening
Participant flow — Screening
MilestoneAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlaceboScreening Only
Started1922202083
Completed192220200
Not completed000083
Withdrew: No reason provided00009
Withdrew: Did not meet eligibility criteria000074
Randomized Period
Participant flow — Randomized Period
MilestoneAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlaceboScreening Only
Started192220200
Completed192013200
Not completed02700
Withdrew: Did not meet inclusion criteria00200
Withdrew: Adverse event02500

Outcome measures

PrimaryChange 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.

Time frame:
Baseline and Week 4.
Reported as:
Least squares mean · Minutes
Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
MinutesAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.6.43 (-12.74 to 25.61)-12.53 (-31.32 to 6.27)-19.41 (-41.91 to 3.08)14.48 (-4.31 to 33.27)
SecondaryChange From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.
Time frame:
Baseline and Week 4.
Reported as:
Least squares mean · % change
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.
% changeAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.0.08 (-3.15 to 3.32)-1.51 (-4.68 to 1.66)-2.82 (-6.61 to 0.97)0.96 (-2.20 to 4.13)
SecondaryChange From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.
Time frame:
Baseline and Week 4.
Reported as:
Least squares mean · Rank transformed duration (minutes)
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.
Rank transformed duration (minutes)AZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.-2.23 (-18.44 to 13.98)14.48 (-1.34 to 30.31)-5.84 (-24.91 to 13.23)-5.68 (-21.54 to 10.18)
SecondaryChange 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

Time frame:
Baseline and Week 4.
Reported as:
Least squares mean · Minutes
Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.
MinutesAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.7.07 (-14.88 to 29.02)-12.42 (-34.92 to 10.07)-18.97 (-45.96 to 8.02)-7.51 (-29.47 to 14.44)
SecondaryChange 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

Time frame:
Baseline and Week 4.
Reported as:
Least squares mean · Minutes
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.
MinutesAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.1.77 (-5.41 to 8.96)9.84 (2.86 to 16.81)-6.85 (-15.50 to 1.81)2.70 (-4.65 to 10.06)
SecondaryChange 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

Time frame:
Baseline and Week 4.
Reported as:
Least squares mean · % (efficiency=% of time asleep)
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.
% (efficiency=% of time asleep)AZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.-0.05 (-3.65 to 3.55)-3.20 (-6.69 to 0.30)-1.92 (-6.20 to 2.35)-1.83 (-5.46 to 1.80)

Adverse events

Collected over From first dose of study drug through the follow-up (up to 38 days total). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AZD5213 Dose A—0/19 (0%)6/19 (31.6%)
AZD5213 Dose B—0/22 (0%)11/22 (50%)
AZD5213 Dose C—1/20 (5%)13/20 (65%)
Placebo—0/20 (0%)8/20 (40%)
Most frequent serious events
Most frequent serious events
EventAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
Transient ischemic attackNervous system disorders0/190/221/200/20
Most frequent other events
Showing 10 of 55
Most frequent other events
EventAZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlacebo
InsomniaPsychiatric disorders0/194/228/200/20
HeadacheNervous system disorders1/194/225/202/20
Night sweatsSkin and subcutaneous tissue disorders0/190/223/200/20
NauseaGastrointestinal disorders1/191/222/201/20
DyspesiaGastrointestinal disorders0/190/222/200/20
RestlessnessPsychiatric disorders0/190/222/200/20
Nasal congestionRespiratory, thoracic and mediastinal disorders0/190/221/202/20
DizzinessNervous system disorders0/192/221/200/20
FallInjury, poisoning and procedural complications1/191/220/200/20
ToothacheGastrointestinal disorders1/190/220/200/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)AZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlaceboTotal
Mean66.1 ± 8.0265.1 ± 8.0469.3 ± 10.3264.2 ± 7.6266.1 ± 8.62
Gender
Gender(Participants)AZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlaceboTotal
Female1216131556
Male767525
Mini-Mental State Examination
Mini-Mental State Examination(Scores on scale)AZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlaceboTotal
Mean27.2 ± 1.3827.0 ± 2.0126.1 ± 1.6227.0 ± 1.8826.8 ± 1.77
Alzheimers disease (AD)/Mild cognitive impairment (MCI)
Alzheimers disease (AD)/Mild cognitive impairment (MCI)(Participants)AZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlaceboTotal
AD365519
MCI1616151562
Concomitant donepezil administration
Concomitant donepezil administration(Participants)AZD5213 Dose AAZD5213 Dose BAZD5213 Dose CPlaceboTotal
Yes21339
No1721171772
08

Study locations

13 sites
  • Research Site
    Phoenix, Arizona, United States
  • Research Site
    Indio, California, United States
  • Research Site
    Lomita, California, United States
  • Research Site
    San Francisco, California, United States
  • Research Site
    Delray Beach, Florida, United States
  • Research Site
    Fort Myers, Florida, United States
  • Research Site
    Hallandale, Florida, United States
  • Research Site
    Orlando, Florida, United States
  • Research Site
    Tampa, Florida, United States
  • Research Site
    Eatontown, New Jersey, United States
  • Research Site
    Brooklyn, New York, United States
  • Research Site
    New York, New York, United States
  • Research Site
    Salt Lake City, Utah, United States
09

References and documents

Publications

  • 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. PubMed 33189083 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01548287
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 8, 2012
Start date
Apr 2012
Primary completion
Jan 2013
Completion
Jan 2013
Results posted
Dec 5, 2016
Last update
Feb 7, 2017

Study contacts

Robert C. Alexander, MD
study director · AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139
Roza Hayduk, MD
study director · Quintiles 10201 Wateridge Circle San Diego, CA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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