Alzheimer's DiseaseNCT00711321
Long-term Safety and Tolerability of AFFITOPE AD02
An observational study of Alzheimer's Disease, run by Affiris AG at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2008to Apr 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects having participated in AFFiRiS 002
Who may be able to join
- Written informed consent signed and dated by patient and caregiver
- Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
- Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits
Who cannot join
- Patients having received no vaccination with AFFITOPE AD02
- History of questionable compliance to visit schedule, patients not expected to finish the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002
The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer, Morbus Alzheimer, Vaccine, Alzheimer Vaccine, A-beta immunotherapy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | AFFITOPE AD02 with adjuvant | |
| 1 | AFFITOPE AD02 without adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term tolerability
Measured: 1 year
Secondary outcomes (1)
Clinical and immunological efficacy (evaluated in an explorative manner only)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionApr 2010
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
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margot Schmitz, MD Univ. D., Principal investigator, Ordination Schmitz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711321
- Sponsor's protocol ID
- Affiris 004
- Other IDs
- EudraCT 2008-002764-33
- Status last verified
- May 2010
- First submitted
- 4 Jul 2008
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002
- ClinicalTrials.gov ID
- NCT00711321
- Acronym / sponsor ID
- Affiris 004
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer, Morbus Alzheimer, Vaccine, Alzheimer Vaccine, A-beta immunotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Jul 2008 (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 the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –AFFITOPE AD02 with adjuvant |
| 1 | – | –AFFITOPE AD02 without adjuvant |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects having participated in AFFiRiS 002
Key inclusion criteria (3 listed)
- Written informed consent signed and dated by patient and caregiver
- Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
- Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits
Key exclusion criteria (2 listed)
- Patients having received no vaccination with AFFITOPE AD02
- History of questionable compliance to visit schedule, patients not expected to finish the clinical trial
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
Long-term tolerability
Time frame: 1 year
1 secondary outcome
Clinical and immunological efficacy (evaluated in an explorative manner only)
Time frame: 1 year
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 27 May 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.
Margot Schmitz, MD Univ. D. principal investigator
Ordination Schmitz
1 site 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 1 site 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 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: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Long-term tolerability (time frame: 1 year). 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 27 May 2010.