A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
NCT ID: NCT01548287
Last Updated: 2017-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
164 participants
INTERVENTIONAL
2012-04-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AZD5213 doseA
AZD5213 doseA daily
AZD5213
AZD5213 doseA daily
AZD5213 doseB
AZD 5213 doseB daily
AZD5213
AZD5213 doseB daily
AZD5213 doseC
AZD5213 doseC daily
AZD5213
AZD5213 doseC daily
Placebo
Placebo daily
Placebo
Placebo tablet daily
Interventions
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AZD5213
AZD5213 doseA daily
AZD5213
AZD5213 doseB daily
AZD5213
AZD5213 doseC daily
Placebo
Placebo tablet daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Robert C. Alexander, MD
Role: STUDY_DIRECTOR
AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139
Roza Hayduk, MD
Role: STUDY_DIRECTOR
Quintiles 10201 Wateridge Circle San Diego, CA
Locations
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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
Countries
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References
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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.
Related Links
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D3030C00005\_Clinical\_Study\_Report\_Synopsis.pdf
Other Identifiers
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D3030C00005
Identifier Type: -
Identifier Source: org_study_id
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