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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548287
• Other study ID #: D3030C00005
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2012
• Last updated: February 21, 2013
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Mild Alzheimer's Disease
• Mild Cognitive Impairment

Intervention

Drug:
• AZD5213
AZD5213 doseA daily
• AZD5213
AZD5213 doseB daily
• AZD5213
AZD5213 doseC daily

Other:
• Placebo
Placebo tablet daily

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Dayton	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	Eatontown	New Jersey
United States	Research Site	Elk Grove Village	Illinois
United States	Reserach Site	Escondido	California
United States	Research Site	Fort Myers	Florida
United States	Research Site	Hickory	North Carolina
United States	Research Site	Indio	California
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Overland Park	Kansas
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	San Francisco	California
United States	Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total sleep time (TST) after 4 weeks of treatment, based on PSG measurement.		Baseline and Week 4.	No
Secondary	Change from baseline in sleep efficiency after 4 weeks of treatment, based on PSG measurements.		Baseline and Week 4.	No
Secondary	Change from baseline in latency to persistent sleep after 4 weeks of treatment, based on PSG measurements.		Baseline and Week 4.	No
Secondary	Change from baseline in night total sleep time after 4 weeks of treatment, based on actigraphy recording.		Baseline and Week 4.	No
Secondary	Change from baseline in sleep onset latency after 4 weeks of treatment, based on actigraphy recording.		Baseline and Week 4.	No