Alzheimer's DiseasePhase 1NCT03113812
Repeated Subcutaneous Administration of ABvac40 in Mild to Moderate Alzheimer's Disease Patients
A Phase 1 study testing ABvac40 in people with Alzheimer's Disease, run by Araclon Biotech S.L..
Trial summary
This first time study in humans was designed to assess tolerability and safety of repeated subcutaneous injections of ABvac40, an active immunization against the C-terminal end of Abeta1-40. 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?
- ABvac40
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Jul 2015
- 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
- Clinical diagnosis suggesting Alzheimer's disease (AD) based on the criteria of the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
- The results of the patient's MRI brain scan had to be concordant with the diagnosis of AD according to the following criteria: Scheltens scale, and quantitative measurement of white matter and past hemorrhages.
- Severity of Alzheimer's disease (AD) assessed as mild or moderate using the Mini Mental State Examination (MMSE) scale. Mild or moderate AD was confirmed if the MMSE score varied between 15 and 26.
- The Hachinski ischemic scale was used to distinguish AD from multi-infarct dementia. A score of ≤4 suggested AD.
- Score on the Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0.
- Be receiving a stable dose of treatment for AD for three months before the selection visit, and expecting to continue treatment for the duration of the study (if appropriate).
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- Stable treatment for other illnesses may be administered 30 days prior to V0 (selection).
- Males or females from 50 to 85 years of age, inclusive (at the time of signing informed consent).
- The patient (or a close relative or legal representative) should read the patient information sheet, agreed to participate in the clinical trial and signed Inform consent (IC) (the patient and a close relative or legal representative).
- Presence of a stable caregiver willing to attend patient visits during the study.
- Sufficient visual and auditory capacity to undertake the neuropsychological tests.
- Positive assessment of the candidate by the investigator for complying with the requirements and procedures of the study.
Who cannot join
- Pregnant women or women of child-bearing age.
- Patients whose general state of health was such that it did not allow completion of the trial or that made taking part in the trial difficult, as judged by the investigator.
- Participation in another clinical trial in the 3 months prior to visit 0 or during the 12 months prior to the selection visit in the case of patients who had participated in trials where the study drug was aimed at modifying the progression of AD.
- Known allergy to the vaccine components or history of anaphylaxis, severe allergic reaction or history of hypersensitivity to any of the components of the formulation.
- Allergy to fish or shellfish.
- Absolute (having a pacemaker or implantable defibrillator) or relative (bare metal stent or stent implanted in the last 6 months) contraindications to MRI examination.
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- Surgery (with general anesthetic) during the 3 months prior to admission into the study and/or surgery planned at any point during the study period.
- History or presence of autoimmune disease.
- Presence or history of immunodeficiency (e.g. HIV).
- Recent history of cancer (≤3 years since the last specific treatment). (Exceptions:
- basal-cell carcinoma, intraepithelial cervical neoplasia).
- Active infectious disease (e.g. hepatitis B, C) or history of chronic viral hepatitis or other chronic hepatic disorders.
- Major systemic condition (e.g. chronic renal failure, chronic hepatopathy, uncontrolled diabetes, uncontrolled congestive heart failure, other deficiencies).
- History of asthma or reactive airway disease presenting as bronchospasm in the last 6 months or currently on a regular anti-asthmatic drug treatment.
- Poorly controlled diseases like poorly controlled hypertension (systolic arterial tension >160 mmHg or diastolic arterial tension >100 mmHg, as an average of 3 measurements) or poorly controlled diabetes according to the investigator's opinion (HbA1c > 12.0).
- Significant alterations in hematological, biochemical or urine analytical parameters, particularly those relating to levels of vitamin B12, folic acid or thyroid tests, and including the possibility of clinically significant anemia.
- Hypothyroidism, defined as any major alteration in thyrotropin (TSH). Patients with corrected hypothyroidism could participate in the study providing that treatment had remained stable for three months immediately prior to admission to the study, and provided that it was ruled out as the cause of or as contributing to the severity of the subject's dementia.
- Positive serology for syphilis (except where neurosyphilis had previously been ruled out).
- History of major psychiatric illness such as schizophrenia, bipolar disorder or major depressive disorder during the last year [according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria)].
- Metabolic or toxic encephalopathy or dementia due to a general medical illness.
- Abuse or excessive consumption of alcohol or drugs according to the DSM-IV criteria.
- Wernicke's encephalopathy.
- History or indications of any other Central Nervous System (CNS) disorder that could be the cause of the dementia (demyelinating, or infectious or inflammatory CNS disease, Creutzfeldt- Jakob disease, Parkinson's disease, Huntington's disease, brain tumor, subdural hematoma, etc.).
- History or indications of cerebrovascular disease (ischemic or hemorrhagic ictus, transient ischemic attack), or diagnosis of possible, probable or definite vascular dementia according to NINDS- Association Internationale pour la Recherché et l'Enseignement en Neurosciences (AIREN) criteria.
- History of intracerebral hemorrhage caused by any of the following: cerebral amyloid angiopathy, uncontrolled hypertension, cerebral arteriovenous malformation, coagulopathy, CNS vasculitis or any other pathology considered by the investigator and/or medical monitor to be a risk factor for intracerebral hemorrhage.
- Prior or current treatment with experimental immunotherapies, including Intravenous Immunoglobulin (IVIG) or vaccines against AD.
- Treatment with systemic corticosteroids or other immunosuppressants during the 30 days prior to visit 0.
- Change in treatments doses for AD or hypothyroidism during the 3 months prior to visit 0.
- Change in dose of drugs for concurrent illnesses appearing in the patient's clinical history during the 30 days prior to visit 1, if they were clinically relevant.
- Patients who had been previously included in the trial, except those patients who failed the screening for reasons that had since been resolved, and so their re-entry into the trial could be considered. Those who received their randomization number and then left the trial remained excluded.
About this study
Official title: A Randomized, Placebo-controlled, Parallel Group, Double-blinded, Single-center Phase-I, Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of ABvac40 in Patients With Mild to Moderate Alzheimer's Disease.
This first time study in humans was designed to assess tolerability and safety of repeated subcutaneous injections of ABvac40, an active immunization against the C-terminal end of Abeta1-40.
- Conditions
- Alzheimer's Disease
- Being tested
- ABvac40, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABvac40Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ABvac40 | Experimental | Not described Receives: Drug: ABvac40 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with adverse events
frequency of adverse events; overall and grouped as neurological, psychiatric and cardiovascular.
Measured: up to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Jan 2014
- Primary completion30 Jul 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Araclon Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113812
- Sponsor's protocol ID
- AB1203
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lacosta AM, Pascual-Lucas M, Pesini P, Casabona D, Perez-Grijalba V, Marcos-Campos I, Sarasa L, Canudas J, Badi H, Monleon I, San-Jose I, Munuera J, Rodriguez-Gomez O, Abdelnour C, Lafuente A, Buendia M, Boada M, Tarraga L, Ruiz A, Sarasa M. Safety, tolerability and immunogenicity of an active anti-Abeta40 vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. Alzheimers Res Ther. 2018 Jan 29;10(1):12. doi: 10.1186/s13195-018-0340-8.
PubMed 29378651
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Parallel Group, Double-blinded, Single-center Phase-I, Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of ABvac40 in Patients With Mild to Moderate Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT03113812
- Acronym / sponsor ID
- AB1203
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Araclon Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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 first time study in humans was designed to assess tolerability and safety of repeated subcutaneous injections of ABvac40, an active immunization against the C-terminal end of Abeta1-40.
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 |
|---|---|---|
| ABvac40 | Experimental | Drug: ABvac40 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinical diagnosis suggesting Alzheimer's disease (AD) based on the criteria of the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).
- The results of the patient's MRI brain scan had to be concordant with the diagnosis of AD according to the following criteria: Scheltens scale, and quantitative measurement of white matter and past hemorrhages.
- Severity of Alzheimer's disease (AD) assessed as mild or moderate using the Mini Mental State Examination (MMSE) scale. Mild or moderate AD was confirmed if the MMSE score varied between 15 and 26.
- The Hachinski ischemic scale was used to distinguish AD from multi-infarct dementia. A score of ≤4 suggested AD.
- Score on the Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0.
Key exclusion criteria (30 listed)
- Pregnant women or women of child-bearing age.
- Patients whose general state of health was such that it did not allow completion of the trial or that made taking part in the trial difficult, as judged by the investigator.
- Participation in another clinical trial in the 3 months prior to visit 0 or during the 12 months prior to the selection visit in the case of patients who had participated in trials where the study drug was aimed at modifying the progression of AD.
- Known allergy to the vaccine components or history of anaphylaxis, severe allergic reaction or history of hypersensitivity to any of the components of the formulation.
- Allergy to fish or shellfish.
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 |
|---|---|---|
| ABvac40 | Drug | ABvac40 |
| Placebo | Drug | Placebo |
Primary outcome
number of participants with adverse events
Time frame: up to week 16
frequency of adverse events; overall and grouped as neurological, psychiatric and cardiovascular.
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 14 Apr 2017.
- Derived from this study: PubMed 29378651Lacosta AM, Pascual-Lucas M, Pesini P, Casabona D, Perez-Grijalba V, Marcos-Campos I, Sarasa L, Canudas J, Badi H, Monleon I, San-Jose I, Munuera J, Rodriguez-Gomez O, Abdelnour C, Lafuente A, Buendia M, Boada M, Tarraga L, Ruiz A, Sarasa M. Safety, tolerability and immunogenicity of an active anti-Abeta40 vaccine (ABvac40) in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase I trial. Alzheimers Res Ther. 2018 Jan 29;10(1):12. doi: 10.1186/s13195-018-0340-8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABvac40 in people with Alzheimer's Disease, run by Araclon Biotech S.L..
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 30 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
number of participants with adverse events (time frame: up to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113812, which also lists 1 linked publication.
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 14 Apr 2017.