CompletedPhase 2Results posted

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, Placebo-Controlled

Lead sponsor

AstraZeneca

Asset

AZD5213

Listed sites

Recruiting sites

Enrollment

164

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Total Sleep Time (TST) After 4 Weeks of Treatment

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD3030C00005

NCT IDNCT01548287

Timeline

Milestones

Study first posted2012-03-08estimated

Study start2012-04 (month precision)

Primary completion2013-01actual (month precision)

Study completion2013-01actual (month precision)

Results first posted2016-12-05estimated

Last update posted2017-02-07estimated

Assets

Drug assets

AZD5213

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

12 endpoints

Primary/protocol endpoint

Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.