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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
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Mild Alzheimer's Disease
Drug: AZD5213
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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, Designed as a Randomized, Double-Blind, Multi-Center, Parallel Group, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD5213 doseA
AZD5213 doseA daily
Drug: AZD5213
AZD5213 doseA daily
Experimental: AZD5213 doseB
AZD 5213 doseB daily
Drug: AZD5213
AZD5213 doseB daily
Experimental: AZD5213 doseC
AZD5213 doseC daily
Drug: AZD5213
AZD5213 doseC daily
Placebo Comparator: Placebo
Placebo daily
Other: Placebo
Placebo tablet daily

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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548287

Locations
United States, California
Reserach Site
Escondido, California, United States
Research Site
Indio, California, United States
Research Site
San Francisco, California, United States
United States, Florida
Research Site
Fort Myers, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Tampa, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Illinois
Research Site
Elk Grove Village, Illinois, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, New Jersey
Research Site
Eatontown, New Jersey, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
Research Site
Hickory, North Carolina, United States
United States, Ohio
Research Site
Dayton, Ohio, United States
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01548287     History of Changes
Other Study ID Numbers: D3030C00005
Study First Received: March 5, 2012
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Mild Cognitive Impairment
Mild Alzheimer's disease
Safety
Tolerability

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 23, 2014