Alzheimer's DiseasePhase 2NCT01097096
Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients
A Phase 2 study testing CAD106, Alum and MF59 in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 31 sites in 10 countries.
Trial summary
This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CAD106, Alum and MF59
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 31 sitesin 10 countries
- Study dates
- Mar 2010to Dec 2012
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and/or female patients below 85 years of age (inclusive)
- Diagnosis of mild Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments
Who cannot join
- Previously participated in an AD vaccine study and received active treatment
- History or presence of an active autoimmune disease
- History or presence of seizure disorder
- Presence of significant coronary heart disease and/or cerebrovascular disease
- Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
- Advanced, severe, progressive or unstable disease that might interfere with the safety, tolerability and pharmacodynamic assessments of the patient
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
31 sites in 10 countries.
31 sites in 10 countries
Italy6 sites
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Roma, RM, 00179
United States5 sites
Novartis Investigative Site
Boulder, Colorado, 80304
Novartis Investigative Site
Costa Mesa, California, 92626
Novartis Investigative Site
Eatontown, New Jersey, 07724
Novartis Investigative Site
Hollywood, Florida, 33021
Novartis Investigative Site
Indianapolis, Indiana, 46202-5266
Spain5 sites
Novartis Investigative Site
Barakaldo, Basque Country, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Barcelona, Catalonia, 08041
Novartis Investigative Site
Sant Cugat del Vallès, Barcelona, 08190
Canada4 sites
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2J2
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Toronto, Ontario, M3B 2S7
Novartis Investigative Site
Toronto, Ontario, M6M 3Z5
Switzerland3 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Biel, 2500
Novartis Investigative Site
Lausanne, 1011
Belgium2 sites
Novartis Investigative Site
Antwerp, 2020
Novartis Investigative Site
Leuven, 3000
Germany2 sites
Novartis Investigative Site
Magdeburg, 39120
Novartis Investigative Site
Nuremberg, 90402
Sweden2 sites
Novartis Investigative Site
Mölndal, 43141
Novartis Investigative Site
Stockholm, SE-141 86
About this study
Official title: A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106
This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- CAD106, Placebo, Alum, MF59
- Keywords
- Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
- Medical subject headings
- Alzheimer Disease, Central Nervous System Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD106Biological
150μg and 450μg doses were reconstituted and administered via intramuscular injection
PlaceboBiological
Identical placebo to CAD106 administered via intramuscular injection
AlumBiological
An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106
MF59Biological
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
| Study group | Role | What they receive |
|---|---|---|
| CAD106 150μg + Adjuvant 1 at middle dose | Active comparator | Not described Receives: Biological: CAD106; Biological: MF59 |
| CAD106 150μg + Adjuvant 1 at low dose | Active comparator | Not described Receives: Biological: CAD106; Biological: MF59 |
| Placebo + Adjuvant 1 at middle dose | Placebo comparator | Not described Receives: Biological: Placebo |
| CAD106 150μg + Adjuvant 2 at middle dose | Active comparator | Not described Receives: Biological: CAD106; Biological: MF59 |
| CAD106 150μg + Adjuvant 2 at low dose | Active comparator | Not described Receives: Biological: CAD106; Biological: MF59 |
| Placebo + Adjuvant 2 at middle dose | Placebo comparator | Not described Receives: Biological: Placebo |
| CAD106 450μg + either Adjuvant 1 or 2 at middle dose | Active comparator | Not described Receives: Biological: CAD106; Biological: Alum; Biological: MF59 |
| CAD106 450μg + either Adjuvant 1 or 2 at low dose | Active comparator | Not described Receives: Biological: CAD106; Biological: Alum; Biological: MF59 |
| Placebo + either Adjuvant 1 or 2 at middle dose | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring).
Measured: Screening and through the end of the study to Week 90
Secondary outcomes (3)
Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)
Measured: Screening and through the end of the study to Week 90
Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)
Measured: Screening and at week 8
Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo
Measured: Screening and through the end of the study to Week 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097096
- Sponsor's protocol ID
- CCAD106A2203
- Other IDs
- 2009-012394-35, 2009
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2010
- Last updated
- 5 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106
- ClinicalTrials.gov ID
- NCT01097096
- Acronym / sponsor ID
- CCAD106A2203
- Conditions
- Alzheimer's Disease
- Keywords
- Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Apr 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 study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| CAD106 150μg + Adjuvant 1 at middle dose | Active comparator | Biological: CAD106, Biological: MF59 |
| CAD106 150μg + Adjuvant 1 at low dose | Active comparator | Biological: CAD106, Biological: MF59 |
| Placebo + Adjuvant 1 at middle dose | Placebo comparator | Biological: Placebo |
| CAD106 150μg + Adjuvant 2 at middle dose | Active comparator | Biological: CAD106, Biological: MF59 |
| CAD106 150μg + Adjuvant 2 at low dose | Active comparator | Biological: CAD106, Biological: MF59 |
| Placebo + Adjuvant 2 at middle dose | Placebo comparator | Biological: Placebo |
| CAD106 450μg + either Adjuvant 1 or 2 at middle dose | Active comparator | Biological: CAD106, Biological: Alum, Biological: MF59 |
| CAD106 450μg + either Adjuvant 1 or 2 at low dose | Active comparator | Biological: CAD106, Biological: Alum, Biological: MF59 |
| Placebo + either Adjuvant 1 or 2 at middle dose | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and/or female patients below 85 years of age (inclusive)
- Diagnosis of mild Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments
Key exclusion criteria (7 listed)
- Previously participated in an AD vaccine study and received active treatment
- History or presence of an active autoimmune disease
- History or presence of seizure disorder
- Presence of significant coronary heart disease and/or cerebrovascular disease
- Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
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 |
|---|---|---|
| CAD106150μg and 450μg doses were reconstituted and administered via intramuscular injection | Biological | CAD106 150μg + Adjuvant 1 at low dose, CAD106 150μg + Adjuvant 1 at middle dose, CAD106 150μg + Adjuvant 2 at low dose, CAD106 150μg + Adjuvant 2 at middle dose, CAD106 450μg + either Adjuvant 1 or 2 at low dose, CAD106 450μg + either Adjuvant 1 or 2 at middle dose |
| PlaceboIdentical placebo to CAD106 administered via intramuscular injection | Biological | Placebo + Adjuvant 1 at middle dose, Placebo + Adjuvant 2 at middle dose, Placebo + either Adjuvant 1 or 2 at middle dose |
| AlumAn adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106 | Biological | CAD106 450μg + either Adjuvant 1 or 2 at low dose, CAD106 450μg + either Adjuvant 1 or 2 at middle dose |
| MF59An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106 | Biological | CAD106 150μg + Adjuvant 1 at low dose, CAD106 150μg + Adjuvant 1 at middle dose, CAD106 150μg + Adjuvant 2 at low dose, CAD106 150μg + Adjuvant 2 at middle dose, CAD106 450μg + either Adjuvant 1 or 2 at low dose, CAD106 450μg + either Adjuvant 1 or 2 at middle dose |
Primary outcome
Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring).
Time frame: Screening and through the end of the study to Week 90
3 secondary outcomes
Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)
Time frame: Screening and through the end of the study to Week 90
Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)
Time frame: Screening and at week 8
Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo
Time frame: Screening and through the end of the study to Week 90
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 5 Mar 2021.
- Resuls for CCAD106A2203 on the Novartis Clinical Trial websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
31 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAD106, Alum and MF59 in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 31 sites in 10 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 3 inclusion and 7 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 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Italy, United States, Spain, Canada, Switzerland and 5 more countries. 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. 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 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 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 assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring). (time frame: Screening and through the end of the study to Week 90). 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 5 Mar 2021.