Alzheimer´s DiseasePhase 2NCT02008513
Follow-up Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in AFF006
A Phase 2 study testing AFFITOPE® AD02 in people with Alzheimer´s Disease, run by Affiris AG at 27 sites in 6 countries.
Trial summary
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months. 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
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Jun 2013to Sep 2014
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
- Written informed consent
- Availability of a partner/caregiver
- Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
- Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.
Who cannot join
- Pregnant women.
- Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
- Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
- History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
- Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
- Contraindication for MRI imaging
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- Presence and/or history of immunodeficiency (e.g., HIV infection).
- Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD02.
- Prior and/or current treatment with immunosuppressive drugs.
- Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
- Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
France7 sites
CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard
Bordeaux, 33076
Hôpital Neurologique Pierre Wertheimer
Bron, 69500
Centre Hospitalier Universitaire (CHU) de Dijon
Dijon, 21033
Centre Mémoire de Ressources et de Recherche, Service de Neurologie
Montpellier, 34295
Hôpital de la Pitié-Salpêtrière
Paris, 75651
CHU de Rennes Site Hôtel Dieu
Rennes, 35064
Hopital La Grave
Toulouse, 31059
Germany7 sites
Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie
Berlin, 14050
Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie
Hamburg, 20251
Arzneimittelforschung Leipzig GmbH, Studienzentrum
Leipzig, 04107
Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie
Mannheim, 68159
Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München
Munich, 81675
Studienzentrum PD Dr. Steinwachs
Nuremberg, 90402
NeuroPoint GmbH
Ulm/Donau, 89073
Austria6 sites
Landeskrankenhaus Hall Gedächtnisambulanz
Hall in Tirol, 6060
LNK Wagner-Jauregg, Dept. of geriatrics
Linz, 4020
Christian Doppler Klinik, Univ. Klinik f. Neurologie
Salzburg, 5020
MUW Klin. Pharmakologie und Klinik für Neurologie
Vienna, 1090
MUW, Klin.Abt.f. Biolog. Psychiatrie
Vienna, 1090
SMZ-Ost, Psychiatric Dep.
Vienna, 1220
Croatia4 sites
Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju
Rijeka, 51000
Opća bolnica Varaždin, Klinika za Neurologiju
Varaždin, 42000
"BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju
Zagreb, 10000
Psihijatrijska Bolnica Vrapče
Zagreb, 10090
Czechia2 sites
University Thomayer Hospital
Prague, 14950
University Hospital Motol, Clinic of Neurology
Prague, 15006
About this study
Official title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.
- Conditions
- Alzheimer´s Disease
- Being tested
- AFFITOPE® AD02, Placebo
- Keywords
- AFFITOPE® AD02, Alzheimer Disease, Dementia, Brain Disease, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Mental Disorders
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFFITOPE® AD02Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations Receives: Biological: AFFITOPE® AD02 |
| Group 2 | Active comparator | AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations Receives: Biological: AFFITOPE® AD02; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measures of Primary Safety and Tolerability Endpoints
- Withdrawal criteria
- Number of Adverse events (AEs)
- Number of any serious adverse events (SAE)
- Alzheimer's Disease Assessment Scale - Cognition (ADAScog)
- Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)
Measured: 19 months
Secondary outcomes (1)
Composite Measures of Secondary Efficacy Endpoints
- Clinical Dementia Rating Sum of Boxes (CDR-sb)
- Free and Cued Selective Reminding Test (FCSRT)
- Standard neuropsychological test battery (CogState)
- Mini-Mental State Examination (MMSE)
- Investigator's global evaluation scale (IGE)
- CDR [global aspects]
- Neuropsychiatric Inventory (NPI) [behavior]
- quality of life (QOL) -AD
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Study AFF006A was early terminated by the sponsor based on the results of study AFF006.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno Dubois, Prof., Principal investigator, Centre des Maladies Cognitives et Comportementales, Federation des maladies du systeme nerveux, Hoptial de la Salpetriere, Pavillon Paul Castaignes (Sous-sol), 47-83 Bd de l'Hopital, 75651 Paris Cedex 13
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008513
- Sponsor's protocol ID
- AFF006A
- Other IDs
- 2012-005280-27
- Status last verified
- Jun 2015
- First submitted
- 30 Oct 2013
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.
- ClinicalTrials.gov ID
- NCT02008513
- Acronym / sponsor ID
- AFF006A
- Conditions
- Alzheimer´s Disease
- Keywords
- AFFITOPE® AD02, Alzheimer Disease, Dementia, Brain Disease, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Mental Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study AFF006A was early terminated by the sponsor based on the results of study AFF006.
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Dec 2013 (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 follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: AFFITOPE® AD02AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations |
| Group 2 | Active comparator | Biological: AFFITOPE® AD02, Biological: PlaceboAFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
- Written informed consent
- Availability of a partner/caregiver
- Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
- Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.
Key exclusion criteria (11 listed)
- Pregnant women.
- Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
- Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
- History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
- Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
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® AD02 | Biological | Group 1, Group 2 |
| Placebo | Biological | Group 2 |
Primary outcome
Composite Measures of Primary Safety and Tolerability Endpoints
Time frame: 19 months
* Withdrawal criteria * Number of Adverse events (AEs) * Number of any serious adverse events (SAE) * Alzheimer's Disease Assessment Scale - Cognition (ADAScog) * Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)
1 secondary outcome
Composite Measures of Secondary Efficacy Endpoints
Time frame: 19 months
Results and safety
The study was stopped early (reason given: Study AFF006A was early terminated by the sponsor based on the results of study AFF006.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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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.
Bruno Dubois, Prof. principal investigator
Centre des Maladies Cognitives et Comportementales, Federation des maladies du systeme nerveux, Hoptial de la Salpetriere, Pavillon Paul Castaignes (Sous-sol), 47-83 Bd de l'Hopital, 75651 Paris Cedex 13
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AFFITOPE® AD02 in people with Alzheimer´s Disease, run by Affiris AG at 27 sites in 6 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 5 inclusion and 11 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Germany, Austria, Croatia, Czechia and 1 more country. 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 was stopped early (reason given: Study AFF006A was early terminated by the sponsor based on the results of study AFF006.). 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?
Composite Measures of Primary Safety and Tolerability Endpoints (time frame: 19 months). 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 24 Jun 2015.