Alzheimer's DiseasePhase 1MimoVaxNCT01309763
Safety and Tolerability of AFFITOPE AD03
A Phase 1 study testing AFFITOPE AD03 and AFFITOPE AD03 + Alum in people with Alzheimer's Disease, run by Affiris AG at 1 site in Austria.
Trial summary
This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I pilot study to assess tolerability and safety of repeated subcutaneous administration of a single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- AFFITOPE AD03 and AFFITOPE AD03 + Alum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Nov 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria.
- Assessing the severity of AD by the Mini Mental State Examination (MMSE). AD of mild degree has been confirmed if the MMSE score is in the range of 20 to 26.
- Hachinski Ischemia Scale is used to try and distinguish AD from multi-infarct dementia. A score of ≤ 4 suggests AD.
- The result of the Magnetic Resonance Imaging scan (MRI) of the patient's brain has to be consistent with the diagnosis of AD
- Written informed consent signed and dated by the patient and the caregiver. The patient's capability to give informed consent has to be confirmed by an independent psychiatrist or neurologist.
- Age between 50 and 80 years.
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- Availability of a partner/caregiver knowing the patient and being able to accompany the patient at the visits and being available for the telephone interviews. This is necessary because some of the neuropsychiatric tests require information by a person knowing the patient well. In addition, it increases the safety of a study participant.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
- Availability of the APOE status
- A potential participant receiving conventional AD and hypothyroidism therapies must be on stable doses for at least 3 months prior to Visit 1 and during the entire trial period.
- A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except AD and hypothyroidism therapy itself which will be recorded separately) for at least 30 days prior to Visit 1, if considered relevant by the investigator.
Who cannot join
- Pregnant women.
- Sexually active women of childbearing potential who are not using a medically accepted birth control method.
- Participation in another clinical trial within 3 months before Visit 1.
- 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 such as metallic endoprosthesis or stent implantation in the last 6 months or allergy to MRI contrast agent.
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- Operation (under general anaesthesia) within 3 months prior to study entry and scheduled elective operation during the whole study period.
- History and/or presence of autoimmune disease, if considered relevant by the investigator.
- Recent (≤3 years since last specific treatment) history of cancer (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia).
- Active infectious disease (e.g., Hepatitis B, C).
- Presence and/or history of Immunodeficiency (e.g., HIV infection).
- Significant systemic illness (e.g., chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, other deficiencies), if considered relevant by the investigator.
- Hypothyroidism, defined as any significant thyroid-stimulating hormone elevation. Patients with corrected hypothyroidism are eligible for the study provided that treatment has been stable for 3 months before study entry.
- History of significant psychiatric illness such as schizophrenia, bipolar affective disorder or psychotic depression.
- Current depressive episode (Geriatric Depression Score (GDS) >5 at visit 1)
- Metabolic or toxic encephalopathy or dementia due to a general medical condition.
- Alcoholism or substance abuse within the past year (alcohol or drug intoxication).
- Wernicke's encephalopathy
- History or evidence of any other CNS disorder that could be interpreted as a cause of dementia (infectious or inflammatory/demyelinating CNS conditions, Creutzfeldt Jacob disease, Parkinson's disease, Huntington's disease, brain tumor, subdural haematoma, etc.)
- History or evidence of cerebrovascular disease (stroke, transient ischemic attack, hemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria.
- Epilepsy
- Prior and/or current treatment with experimental immunotherapeutics including IVIG or vaccines for AD.
- Prior and/or current treatment with immunosuppressive drugs.
- Change in dose of standard treatments for AD or hypothyroidism within 3 months prior to visit 1.
- Change in dose of previous and current medications which the patient is taking because of consisting illnesses according medical history (except AD and hypothyroidism therapies, AD therapies will be recorded separately) within the last 30 days prior to visit 1, if clinically relevant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess the Tolerability and Safety of Repeated Administrations of a Single-dose of AFFITOPE AD03 to Alzheimer's Disease Patients
This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I pilot study to assess tolerability and safety of repeated subcutaneous administration of a single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- AFFITOPE AD03, AFFITOPE AD03 + Alum
- 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 AD03Biological
s.c. injection
AFFITOPE AD03 + AlumBiological
s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| AFFITOPE AD03 | Active comparator | s.c. injection Receives: Biological: AFFITOPE AD03 |
| AFFITOPE AD03 + Alum | Experimental | s.c. injection Receives: Biological: AFFITOPE AD03 + Alum |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in ADAS-Cog score as a measure of cognition
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2011
- Study completionNov 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiris AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siegfried Kasper, MD, Principal investigator, MUW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309763
- Sponsor's protocol ID
- AFF005A
- Acronym
- MimoVax
- Status last verified
- Dec 2011
- First submitted
- 2 Sep 2009
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess the Tolerability and Safety of Repeated Administrations of a Single-dose of AFFITOPE AD03 to Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT01309763
- Acronym / sponsor ID
- MimoVax / AFF005A
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Affiris AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Mar 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 is a randomized, controlled, parallel group, patient-blinded, single-center, phase I pilot study to assess tolerability and safety of repeated subcutaneous administration of a single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to moderate Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFFITOPE AD03 | Active comparator | Biological: AFFITOPE AD03s.c. injection |
| AFFITOPE AD03 + Alum | Experimental | Biological: AFFITOPE AD03 + Alums.c. injection |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of probable Alzheimer's disease based on the NINCDS/ADRDA criteria.
- Assessing the severity of AD by the Mini Mental State Examination (MMSE). AD of mild degree has been confirmed if the MMSE score is in the range of 20 to 26.
- Hachinski Ischemia Scale is used to try and distinguish AD from multi-infarct dementia. A score of ≤ 4 suggests AD.
- The result of the Magnetic Resonance Imaging scan (MRI) of the patient's brain has to be consistent with the diagnosis of AD
- Written informed consent signed and dated by the patient and the caregiver. The patient's capability to give informed consent has to be confirmed by an independent psychiatrist or neurologist.
Key exclusion criteria (25 listed)
- Pregnant women.
- Sexually active women of childbearing potential who are not using a medically accepted birth control method.
- Participation in another clinical trial within 3 months before Visit 1.
- 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 AD03s.c. injection | Biological | AFFITOPE AD03 |
| AFFITOPE AD03 + Alums.c. injection | Biological | AFFITOPE AD03 + Alum |
Primary outcome
change in ADAS-Cog score as a measure of cognition
Time frame: 12 months
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 20 Dec 2011.
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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, MD principal investigator
MUW
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 AD03 and AFFITOPE AD03 + Alum 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 12 inclusion and 25 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 20 Dec 2011. 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?
change in ADAS-Cog score as a measure of cognition (time frame: 12 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 20 Dec 2011.