Alzheimer DiseasePhase 2SiroccoNCT00501111
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
A Phase 2 study testing AZD3480 and Donepezil in people with Alzheimer Disease, run by AstraZeneca at 70 sites in 10 countries.
Trial summary
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in future trials. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AZD3480 and Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 70 sitesin 10 countries
- Study dates
- Jul 2007to Aug 2008
- 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
- Provision of informed consent from patient and caregiver
- Clinical prognosis of probable Alzheimer's disease
- Patient must have a caregiver visiting the patient at least three times weekly
Who cannot join
- Significant neurologic disease or dementia other than Alzheimer's disease
- Major depressive disorder, other major psychiatric disorder
- Use of acetylcholinesterase inhibitor or memantine for treatment of Alzheimer's disease within 8 weeks prior to enrollment
- Impaired vision and/or hearing making cognitive testing difficult
Trial locations and contacts
70 sites in 10 countries.
70 sites in 10 countries
Germany12 sites
Research Site
Bad Saarow
Research Site
Berlin
Research Site
Dresden
Research Site
Freiburg im Breisgau
Research Site
Heidelberg
Research Site
Kiel-kronshagen
Research Site
Leipzig
Research Site
Lübeck
Research Site
Magdeburg
Research Site
Mannheim
Research Site
München
Research Site
Nuremberg
Canada10 sites
Research Site
Calgary, Alberta
Research Site
Edmonton, Alberta
Research Site
Greenfield Park, Quebec
Research Site
Ottawa, Ontario
Research Site
Peterborough, Ontario
Research Site
Québec, Quebec
Research Site
Regina, Saskatchewan
Research Site
Toronto, Ontario
Research Site
Verdun, Quebec
Research Site
Winnipeg, Manitoba
Czechia10 sites
Research Site
Brno
Research Site
Havlíčkův Brod
Research Site
Hradec Králové
Research Site
Kladno
Research Site
Litoměřice
Research Site
Nový Jičín
Research Site
Olomouc
Research Site
Ostrava - Poruba
Research Site
Prague
Research Site
Prostějov
Spain9 sites
Research Site
Baracaldo (vizcaya)
Research Site
Barcelona, Catalonia
Research Site
Castellon, Valencia
Research Site
Hospitalet de Llobregat(barcel, Catalonia
Research Site
Madrid, Madrid
Research Site
Palma de Mallorca, Balearic Islands
Research Site
Salamanca, Castille and León
Research Site
Salt (girona), Catalonia
Research Site
Terrassa, Catalonia
United Kingdom7 sites
Research Site
Blackpool, Lancashire
Research Site
Bradford
Research Site
London
Research Site
Peterborough
Research Site
Southampton, Hampshire
Research Site
Swindon
Research Site
Uckfield, E Sussex
Belgium5 sites
Research Site
Aalst, Belgium
Research Site
Antwerp, Belgium
Research Site
Hasselt, Belgium
Research Site
Leuven, Belgium
Research Site
Sint-Truiden, Belgium
Bulgaria5 sites
Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Romania5 sites
Research Site
Bucharest
Research Site
Iași
Research Site
Piteşti, Argeş
Research Site
Sibiu
Research Site
Târgu Mureş, Mureș County
Austria4 sites
Research Site
Graz, Osterreich
Research Site
Innsbruck, Osterreich
Research Site
Linz
Research Site
Vienna, Osterreich
Russia3 sites
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Smolensk
About this study
Official title: A Multi-centre, Double-blind, Double-dummy, Placebo Controlled Parallel Group Randomized Phase IIb Proof of Concept Study With 3 Oral Dose Groups of AZD3480 or Donepezil During 12 Weeks Treatment in Patients With Alzheimer's Disease
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in future trials.
- Conditions
- Alzheimer Disease
- Being tested
- AZD3480, Donepezil
- Keywords
- Dementia, Alzheimer Type, Alzheimer Disease
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3480Drug
3 oral doses
DonepezilDrug
Also called Aricept
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Placebo |
| 2 | Active comparator | donepezil Receives: Drug: Donepezil |
| 3 | Experimental | AZD3480 Receives: Drug: AZD3480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADAS-Cog
Measured: assessed after 12 weeks treatment
Secondary outcomes (1)
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE
Measured: assessed after 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AZD3480, Medical Science Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501111
- Sponsor's protocol ID
- D3690C00010
- Other IDs
- EuDract 2007-00835-24
- Acronym
- Sirocco
- Status last verified
- Jul 2014
- First submitted
- 12 Jul 2007
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Double-blind, Double-dummy, Placebo Controlled Parallel Group Randomized Phase IIb Proof of Concept Study With 3 Oral Dose Groups of AZD3480 or Donepezil During 12 Weeks Treatment in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00501111
- Acronym / sponsor ID
- Sirocco / D3690C00010
- Conditions
- Alzheimer Disease
- Keywords
- Dementia, Alzheimer Type, Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Jul 2007 (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 demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in future trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Placebo |
| 2 | Active comparator | Drug: Donepezildonepezil |
| 3 | Experimental | Drug: AZD3480AZD3480 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of informed consent from patient and caregiver
- Clinical prognosis of probable Alzheimer's disease
- Patient must have a caregiver visiting the patient at least three times weekly
Key exclusion criteria (4 listed)
- Significant neurologic disease or dementia other than Alzheimer's disease
- Major depressive disorder, other major psychiatric disorder
- Use of acetylcholinesterase inhibitor or memantine for treatment of Alzheimer's disease within 8 weeks prior to enrollment
- Impaired vision and/or hearing making cognitive testing difficult
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 |
|---|---|---|
| AZD34803 oral doses | Drug | 3 |
| DonepezilAlso: Aricept | Drug | 2 |
Primary outcome
Change in ADAS-Cog
Time frame: assessed after 12 weeks treatment
1 secondary outcome
Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE
Time frame: assessed after 12 weeks treatment
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 23 Jul 2014.
- D3690C00010 Clinical Stusy Report SynopsisLink 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.
AstraZeneca AZD3480, Medical Science Director study director
AstraZeneca
70 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD3480 and Donepezil in people with Alzheimer Disease, run by AstraZeneca at 70 sites in 10 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 4 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 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Germany, Canada, Czechia, Spain, United Kingdom and 5 more countries. 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. 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?
Change in ADAS-Cog (time frame: assessed after 12 weeks treatment). 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 23 Jul 2014.