Mild Cognitive ImpairmentPhase 2NCT01548287
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
A Phase 2 study testing AZD5213 in people with Mild Cognitive Impairment and Mild Alzheimer's Disease, run by AstraZeneca at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Mild Alzheimer's Disease
- What is being tested?
- AZD5213
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Research Site
Brooklyn, New York
Research Site
Delray Beach, Florida
Research Site
Eatontown, New Jersey
Research Site
Fort Myers, Florida
Research Site
Hallandale, Florida
Research Site
Indio, California
Research Site
Lomita, California
Research Site
New York, New York
Research Site
Orlando, Florida
Research Site
Phoenix, Arizona
Research Site
Salt Lake City, Utah
Research Site
San Francisco, California
Research Site
Tampa, Florida
About this study
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, Placebo-Controlled
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.
Read the 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
- Being tested
- AZD5213, Placebo
- Keywords
- Mild Cognitive Impairment, Mild Alzheimer's disease, Safety, Tolerability
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5213Drug
AZD5213 doseA daily
AZD5213Drug
AZD5213 doseB daily
AZD5213Drug
AZD5213 doseC daily
PlaceboOther
Placebo tablet daily
| Study group | Role | What they receive |
|---|---|---|
| AZD5213 doseA | Experimental | AZD5213 doseA daily Receives: Drug: AZD5213 |
| AZD5213 doseB | Experimental | AZD 5213 doseB daily Receives: Drug: AZD5213 |
| AZD5213 doseC | Experimental | AZD5213 doseC daily Receives: Drug: AZD5213 |
| Placebo | Placebo comparator | Placebo daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
Measured: Baseline and Week 4.
Secondary outcomes (5)
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.
Measured: Baseline and Week 4.
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.
Measured: Baseline and Week 4.
Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.
Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data
Measured: Baseline and Week 4.
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.
Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Measured: Baseline and Week 4.
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.
Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data
Measured: Baseline and Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert C. Alexander, MD, Study director, AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139Roza Hayduk, MD, Study director, Quintiles 10201 Wateridge Circle San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548287
- Sponsor's protocol ID
- D3030C00005
- Status last verified
- Dec 2016
- First submitted
- 5 Mar 2012
- Last updated
- 7 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33189083
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Placebo-Controlled
- ClinicalTrials.gov ID
- NCT01548287
- Acronym / sponsor ID
- D3030C00005
- Keywords
- Mild Cognitive Impairment, Mild Alzheimer's disease, Safety, Tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AZD5213 doseA | Experimental | Drug: AZD5213AZD5213 doseA daily |
| AZD5213 doseB | Experimental | Drug: AZD5213AZD 5213 doseB daily |
| AZD5213 doseC | Experimental | Drug: AZD5213AZD5213 doseC daily |
| Placebo | Placebo comparator | Other: PlaceboPlacebo daily |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5213AZD5213 doseA daily | Drug | AZD5213 doseA |
| AZD5213AZD5213 doseB daily | Drug | AZD5213 doseB |
| AZD5213AZD5213 doseC daily | Drug | AZD5213 doseC |
| PlaceboPlacebo tablet daily | Other | Placebo |
Primary outcome
Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.
Time frame: Baseline and Week 4.
Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.
5 secondary outcomes
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.
Time frame: Baseline and Week 4.
Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.
Time frame: Baseline and Week 4.
Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.
Time frame: Baseline and Week 4.
Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.
Time frame: Baseline and Week 4.
Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.
Time frame: Baseline and Week 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33189083McCleery 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.
- D3030C00005\_Clinical\_Study\_Report\_Synopsis.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Alexander, MD study director
AstraZeneca Research & Development, Neuroscience iMed, 141 Portland Street, Cambridge, MA 02139
Roza Hayduk, MD study director
Quintiles 10201 Wateridge Circle San Diego, CA
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5213 in people with Mild Cognitive Impairment and Mild Alzheimer's Disease, run by AstraZeneca at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01548287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.