Alzheimer´s DiseaseNCT01357629
Observational Follow-up Extension Study of AFF002 and AFF004A in Patients With Alzheimer's Disease
An observational study of Alzheimer´s Disease, run by Affiris AG at 2 sites in Austria.
Trial summary
This study examines the long term Safety Follow-up of first patients vaccinated with AD02. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer´s Disease
- How many people
- 11 participants
- Where
- 2 sitesAustria
- Study dates
- Jul 2011to Nov 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Alzheimer´s Disease
Who may be able to join
- participation in AFF002 and AFF004A
Who cannot join
- no vaccination with AD02
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Studienzentrum der PROSENEX Ambulatoriumsbetriebs GmbH
Vienna, State of Vienna, 1080
Univ. Klinik für Psychiatire und Psychotherapie
Vienna, 1090
About this study
Official title: Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunizations With AFFITOPE AD02 Applied During AFFiRiS002 and AFF004A in Patients With Alzheimer's Disease
This study examines the long term Safety Follow-up of first patients vaccinated with AD02.
Read the detailed description
Patients who have received AD02 during AFF002 and AFF004A will be observed.
- Conditions
- Alzheimer´s Disease
- Keywords
- Vaccination follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
collection and evaluation of AEs, SAEs
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2013
- Study completionNov 2013
Why it stopped: The Study could not be done for every potential participant as planned in the protocol for organizational reasons.
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Achim Schneeberger, MD, Study director, Sponsor GmbHSiegfried Kasper, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357629
- Sponsor's protocol ID
- AFF004E
- Status last verified
- Dec 2013
- First submitted
- 21 Mar 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Follow-up Extension Study to Evaluate Long-term Safety and Tolerability of Immunizations With AFFITOPE AD02 Applied During AFFiRiS002 and AFF004A in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01357629
- Acronym / sponsor ID
- AFF004E
- Conditions
- Alzheimer´s Disease
- Keywords
- Vaccination follow-up
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Study could not be done for every potential participant as planned in the protocol for organizational reasons.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 May 2011 (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.
This study examines the long term Safety Follow-up of first patients vaccinated with AD02.
Detailed description
Patients who have received AD02 during AFF002 and AFF004A will be observed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alzheimer´s Disease
Key inclusion criteria (1 listed)
- participation in AFF002 and AFF004A
Key exclusion criteria (1 listed)
- no vaccination with AD02
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety
Time frame: up to 2 years
collection and evaluation of AEs, SAEs
Results and safety
The study was stopped early (reason given: The Study could not be done for every potential participant as planned in the protocol for organizational reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
Achim Schneeberger, MD study director
Sponsor GmbH
Siegfried Kasper, MD principal investigator
Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer´s Disease, run by Affiris AG at 2 sites in Austria.
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 1 inclusion and 1 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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.
Are results available for this study?
The study was stopped early (reason given: The Study could not be done for every potential participant as planned in the protocol for organizational reasons.). 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?
Safety (time frame: up to 2 years). 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 Dec 2013.