Alzheimer's DiseasePhase 1NCT01093664
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02
A Phase 1 study testing AFFITOPE AD02 in people with Alzheimer's Disease, run by Affiris AG at 1 site in Austria.
Trial summary
This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- AFFITOPE AD02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2009to Jul 2010
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in AFF002 and AFF004
Who cannot join
- Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
- Contraindication for MRI imaging
- History and/or presence of autoimmune disease, if considered relevant by the investigator
- Active infectious disease (e.g., Hepatitis B, C)
- Presence and/or history of Immunodeficiency (e.g., HIV)
- Significant systemic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IB Follow-up Study to Assess a Boost Immunization With AFFITOPE AD02 With Regard to Safety/Tolerability, Immunological and Clinical Activity in Alzheimer Patients Who Have Received the Vaccine Within the Clinical Study AFF002
This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.
- Conditions
- Alzheimer's Disease
- Being tested
- AFFITOPE AD02
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFFITOPE AD02Biological
s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| AFFITOPE AD02 | Experimental | Not described Receives: Biological: AFFITOPE AD02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
- Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal
- Adverse events (AEs)
- Serious adverse events (SAEs)
- Physical and neurological examination
- Concomitant medication
- Vital signs (blood pressure, heart rate, respiratory rate, body temperature)
- Body mass (weight and height)
- MRI of brain
- ECG
- Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis)
Measured: July 2010
Secondary outcomes (1)
Immunological and clinical activity
Immunological parameters:
- Assessment of the immune response triggered by the vaccine (titre of IgG antibodies specific for the immunizing peptide, N-terminal part of Aβ, (irrelevant peptide serves as specificity control), Aβ itself and KLH as assessed by ELlSA as well as the results of the biacore affinity measurements towards the immunizing peptide and Aβ)
Clinical efficacy variables:
- Cognitive and functional tests, behavioural scales
- Measurement of quality of life in patients with Alzheimer's disease
- Investigator's global evaluation scale
Measured: July 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startOct 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 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margot Schmitz, Univ. Doz., Principal investigator, Ordination Schmitz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093664
- Sponsor's protocol ID
- AFF004A
- Status last verified
- Oct 2010
- First submitted
- 2 Sep 2009
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB Follow-up Study to Assess a Boost Immunization With AFFITOPE AD02 With Regard to Safety/Tolerability, Immunological and Clinical Activity in Alzheimer Patients Who Have Received the Vaccine Within the Clinical Study AFF002
- ClinicalTrials.gov ID
- NCT01093664
- Acronym / sponsor ID
- AFF004A
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Mar 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.
This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AFFITOPE AD02 | Experimental | Biological: AFFITOPE AD02 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in AFF002 and AFF004
Key exclusion criteria (6 listed)
- Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
- Contraindication for MRI imaging
- History and/or presence of autoimmune disease, if considered relevant by the investigator
- Active infectious disease (e.g., Hepatitis B, C)
- Presence and/or history of Immunodeficiency (e.g., HIV)
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 |
|---|---|---|
| AFFITOPE AD02s.c. injection | Biological | AFFITOPE AD02 |
Primary outcome
Safety and Tolerability
Time frame: July 2010
* Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Adverse events (AEs) * Serious adverse events (SAEs) * Physical and neurological examination * Concomitant medication * Vital signs (blood pressure, heart rate, respiratory rate, body temperature) * Body mass (weight and height) * MRI of brain * ECG * Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis)
1 secondary outcome
Immunological and clinical activity
Time frame: July 2010
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 19 Oct 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, Univ. Doz. 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?
A Phase 1 study testing AFFITOPE AD02 in people with 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 1 inclusion and 6 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 19 Oct 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and Tolerability (time frame: July 2010). 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 19 Oct 2010.