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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01548287
First received: March 5, 2012
Last updated: February 21, 2013
Last verified: February 2013

March 5, 2012
February 21, 2013
April 2012
January 2013   (final data collection date for primary outcome measure)
Change from baseline in total sleep time (TST) after 4 weeks of treatment, based on PSG measurement. [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01548287 on ClinicalTrials.gov Archive Site
  • Change from baseline in sleep efficiency after 4 weeks of treatment, based on PSG measurements. [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
  • Change from baseline in latency to persistent sleep after 4 weeks of treatment, based on PSG measurements. [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
  • Change from baseline in night total sleep time after 4 weeks of treatment, based on actigraphy recording. [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
  • Change from baseline in sleep onset latency after 4 weeks of treatment, based on actigraphy recording. [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mild Cognitive Impairment
  • Mild Alzheimer's Disease
  • Drug: AZD5213
    AZD5213 doseA daily
  • Drug: AZD5213
    AZD5213 doseB daily
  • Drug: AZD5213
    AZD5213 doseC daily
  • Other: Placebo
    Placebo tablet daily
  • Experimental: AZD5213 doseA
    AZD5213 doseA daily
    Intervention: Drug: AZD5213
  • Experimental: AZD5213 doseB
    AZD 5213 doseB daily
    Intervention: Drug: AZD5213
  • Experimental: AZD5213 doseC
    AZD5213 doseC daily
    Intervention: Drug: AZD5213
  • Placebo Comparator: Placebo
    Placebo daily
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01548287
D3030C00005
Not Provided
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP