Mild to Moderate Alzheimer's DiseasePhase 2ROBINNCT01039701
4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing AZD1446 in people with Mild to Moderate Alzheimer's Disease, run by AstraZeneca at 12 sites in 3 countries.
Trial summary
The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Mild to Moderate Alzheimer's Disease
- What is being tested?
- AZD1446
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Dec 2009to Jul 2010
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of progressive worsening of memory and other cognitive functions for at least 12 months
- treatment with stable dose of donepezil (10 mg) for at least 3 months
- the patient should have an appropriate caregiver, who is required for all study visits
Who cannot join
- history of allergy/hypersensitivity reactions
- significant neurological disease or dementia other than Alzheimer's disease
- myocardial infarction or acute coronary syndrome within the last year
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Hungary6 sites
Research Site
Debrecen
Research Site
Esztergom
Research Site
Miskolc
Research Site
Nagykálló
Research Site
Nyíregyháza
Research Site
Szeged
Czechia3 sites
Research Site
Litoměřice
Research Site
Prague
Research Site
Praha 10 - Strasnice
Slovakia3 sites
Research Site
Bratislava
Research Site
Rožňava
Research Site
Zlaté Moravce
About this study
Official title: Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment
The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.
- Conditions
- Mild to Moderate Alzheimer's Disease
- Being tested
- AZD1446, Placebo
- Keywords
- safety, tolerability, mild to moderate Alzheimer's disease, To determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil in patients with mild to moderate Alzheimer's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1446Drug
capsules, oral, 3 times daily
PlaceboDrug
capsules, oral, 3 times daily, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD1446 60mg once daily + donepezil 10mg Receives: Drug: AZD1446 |
| 2 | Experimental | AZD1446 60mg three times daily + donepezil 10mg Receives: Drug: AZD1446 |
| 3 | Experimental | AZD1446 30mg three times daily + donepezil 10mg Receives: Drug: AZD1446 |
| 4 | Placebo comparator | placebo + donepezil 10mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature and incidence of adverse events
Measured: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.
Secondary outcomes (3)
To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil
Measured: Twice during the study: at Visit 2 and Visit 10.
To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients
Measured: Twice during the study: at Visit 8 and Visit 10.
To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC
Measured: Baseline assessment at Visit 2 and a follow-up assessment at Visit 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039701
- Sponsor's protocol ID
- D1950C00006
- Acronym
- ROBIN
- Status last verified
- Aug 2010
- First submitted
- 20 Dec 2009
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment
- ClinicalTrials.gov ID
- NCT01039701
- Acronym / sponsor ID
- ROBIN / D1950C00006
- Conditions
- Mild to Moderate Alzheimer's Disease
- Keywords
- safety, tolerability, mild to moderate Alzheimer's disease, To determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil in patients with mild to moderate Alzheimer's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Dec 2009 (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 primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1446AZD1446 60mg once daily + donepezil 10mg |
| 2 | Experimental | Drug: AZD1446AZD1446 60mg three times daily + donepezil 10mg |
| 3 | Experimental | Drug: AZD1446AZD1446 30mg three times daily + donepezil 10mg |
| 4 | Placebo comparator | Drug: Placeboplacebo + donepezil 10mg |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- history of progressive worsening of memory and other cognitive functions for at least 12 months
- treatment with stable dose of donepezil (10 mg) for at least 3 months
- the patient should have an appropriate caregiver, who is required for all study visits
Key exclusion criteria (3 listed)
- history of allergy/hypersensitivity reactions
- significant neurological disease or dementia other than Alzheimer's disease
- myocardial infarction or acute coronary syndrome within the last year
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 |
|---|---|---|
| AZD1446capsules, oral, 3 times daily | Drug | 1, 2, 3 |
| Placebocapsules, oral, 3 times daily, 4 weeks | Drug | 4 |
Primary outcome
Nature and incidence of adverse events
Time frame: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.
3 secondary outcomes
To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil
Time frame: Twice during the study: at Visit 2 and Visit 10.
To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients
Time frame: Twice during the study: at Visit 8 and Visit 10.
To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC
Time frame: Baseline assessment at Visit 2 and a follow-up assessment at Visit 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1446 in people with Mild to Moderate Alzheimer's Disease, run by AstraZeneca at 12 sites in 3 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 3 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 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Hungary, Czechia, Slovakia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nature and incidence of adverse events (time frame: From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.). 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 11 Aug 2010.