Alzheimer's DiseaseNCT01568086
Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A
An observational study of Alzheimer's Disease, run by Affiris AG at 2 sites in Austria.
Trial summary
This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 16 participants
- Where
- 2 sitesAustria
- Study dates
- Dec 2011to Oct 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mild to moderate Alzheimer's disease (MMSE 16 to 26)that have participated in AFF005A
Who may be able to join
- Written informed consent signed and dated by the patient and the caregiver.
- Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03
- Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls
Who cannot join
- Patients having received no vaccination with AFFITOPE AD03
- History of questionable compliance to visit schedule; patients not expected to complete the clinical trial
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Studienzentrum der PROSENEX, AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt
Vienna, 1080
Medical University of Vienna, Department for Psychiatry and Psychotherapy
Vienna, 1090
About this study
Official title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A
This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.
- Conditions
- Alzheimer's Disease
- 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 |
|---|---|---|
| AFFITOPE AD03 with adjuvant | Not described | |
| AFFITOPE AD03 without adjuvant | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability
- Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal
- Number and kind (description) of AEs
- Number and kind (description) of SAEs
- Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis)
Measured: 52 weeks
Secondary outcomes (2)
Clinical Efficacy
Changes from study AFF005A in:
- CIBIC plus (Clinician's Interview-Based Impression of Change, + carer interview)
- ADAScog (Alzheimer Disease Assessment Scale-cognitive)
- CERAD plus (The Consortium to Establish a Registry for AD)
- Neuropsychiatric inventory
- Activity of daily living
- Quality of life in patients with Alzheimer's disease
- Investigator's global evaluation scale
- MRI brain volumetry
Measured: 52 weeks
Immunological
- Titre of antibodies specific for the immunizing peptide, N-terminal part of Aβ, Aβ itself, N-terminally truncated and Pyroglutamate-modified versions of Aβ, and KLH by ELlSA
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionOct 2013
Why it stopped: The study could not be performed as planned 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
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siegfried Kasper, Prof.Dr., Principal investigator, Medical University of Vienna ,Department for Psychiatry and PsychotherapyDieter Volc, Prim. Dr., Principal investigator, Studienzentrum der PROSENEX,AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568086
- Sponsor's protocol ID
- AFF005B
- Status last verified
- Nov 2013
- First submitted
- 16 Dec 2011
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. 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 AD03 Applied During AFFiRiS 005A
- ClinicalTrials.gov ID
- NCT01568086
- Acronym / sponsor ID
- AFF005B
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study could not be performed as planned for organizational reasons.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Apr 2012 (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 evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFFITOPE AD03 with adjuvant | – | – |
| AFFITOPE AD03 without adjuvant | – | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild to moderate Alzheimer's disease (MMSE 16 to 26)that have participated in AFF005A
Key inclusion criteria (3 listed)
- Written informed consent signed and dated by the patient and the caregiver.
- Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03
- Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls
Key exclusion criteria (2 listed)
- Patients having received no vaccination with AFFITOPE AD03
- History of questionable compliance to visit schedule; patients not expected to complete 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
Safety/Tolerability
Time frame: 52 weeks
* Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Number and kind (description) of AEs * Number and kind (description) of SAEs * Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis)
2 secondary outcomes
Clinical Efficacy
Time frame: 52 weeks
Immunological
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: The study could not be performed as planned for organizational reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
Siegfried Kasper, Prof.Dr. principal investigator
Medical University of Vienna ,Department for Psychiatry and Psychotherapy
Dieter Volc, Prim. Dr. principal investigator
Studienzentrum der PROSENEX,AmbulatoriumbetriebsgesmbH an derConfraternität-Privatklinik Josefstadt
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 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: stopped early, as of the sponsor's last update on 6 Nov 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 performed as planned 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/Tolerability (time frame: 52 weeks). 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 6 Nov 2013.