Alzheimer´s DiseasePhase 2NCT01125683
To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease
A Phase 2 study testing AZD1446 and Donepezil in people with Alzheimer´s Disease, run by AstraZeneca at 7 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer´s Disease
- What is being tested?
- AZD1446 and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of probable Alzheimer´s Disease
- Hachinski Ischaemic score < 4
- MSE score 18 to 24
Who cannot join
- History of any clinically significant disease or dementia other than Alzheimer´s Disease
- Current major depressive disorder or other major psychiatric disorders
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Ukraine4 sites
Research Site
Dnipropetrovsk
Research Site
Kiev, Ukraine
Research Site
Luhansk
Research Site
Vinnytsia
Russia3 sites
Research Site
Kazan'
Research Site
Moscow
Research Site
Saint Petersburg
About this study
Official title: A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography and Event-Related Potentials in Patients With AD
The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.
- Conditions
- Alzheimer´s Disease
- Being tested
- AZD1446, Donepezil, Placebo
- Keywords
- Phase II, Alzheimer's disease, EEG, cognition, pharmacodynamic
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1446Drug
Capsule, oral single and multiple dose
DonepezilDrug
Capsule, oral and single dose
PlaceboDrug
Capsule, oral and single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2,5 mg once daily Receives: Drug: AZD1446 |
| 2 | Active comparator | single dose of 5 mg Receives: Drug: Donepezil |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| 4 | Experimental | 60 mg once daily Receives: Drug: AZD1446 |
| 5 | Experimental | 60 mg three times daily Receives: Drug: AZD1446 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.
Measured: collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each.
Secondary outcomes (3)
To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.
Measured: Information on these will be collected from the time of randomization, throughout the study.
To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable
Measured: Information on these will be collected from the time of informed consent is signed, throughout the study.
Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.
Measured: Information on these will be collected from the time of informed consent is signed, throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Poor recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer´s DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Märta Segerdahl, MD, PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125683
- Sponsor's protocol ID
- D1950C00011
- Other IDs
- 2010-018273-38
- Status last verified
- May 2011
- First submitted
- 13 May 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography and Event-Related Potentials in Patients With AD
- ClinicalTrials.gov ID
- NCT01125683
- Acronym / sponsor ID
- D1950C00011
- Conditions
- Alzheimer´s Disease
- Keywords
- Phase II, Alzheimer's disease, EEG, cognition, pharmacodynamic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD14462,5 mg once daily |
| 2 | Active comparator | Drug: Donepezilsingle dose of 5 mg |
| 3 | Placebo comparator | Drug: Placebo |
| 4 | Experimental | Drug: AZD144660 mg once daily |
| 5 | Experimental | Drug: AZD144660 mg three times daily |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of probable Alzheimer´s Disease
- Hachinski Ischaemic score < 4
- MSE score 18 to 24
Key exclusion criteria (2 listed)
- History of any clinically significant disease or dementia other than Alzheimer´s Disease
- Current major depressive disorder or other major psychiatric disorders
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 |
|---|---|---|
| AZD1446Capsule, oral single and multiple dose | Drug | 1, 4, 5 |
| DonepezilCapsule, oral and single dose | Drug | 2 |
| PlaceboCapsule, oral and single dose | Drug | 3 |
Primary outcome
To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.
Time frame: collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each.
3 secondary outcomes
To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.
Time frame: Information on these will be collected from the time of randomization, throughout the study.
To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable
Time frame: Information on these will be collected from the time of informed consent is signed, throughout the study.
Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.
Time frame: Information on these will be collected from the time of informed consent is signed, throughout the study.
Results and safety
The study was stopped early (reason given: Poor recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
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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.
Märta Segerdahl, MD, PhD study director
AstraZeneca
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1446 and Donepezil in people with Alzheimer´s Disease, run by AstraZeneca at 7 sites in 2 countries.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Ukraine, Russia. 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?
The study was stopped early (reason given: Poor recruitment.). Results are not available in the source record.
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?
To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD. (time frame: collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2011.