Alzheimer DiseasePhase 2NCT01023685
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
A Phase 2 study testing CAD106 in people with Alzheimer Disease, run by Novartis at 8 sites in United States.
Trial summary
This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- CAD106
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2009to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have completed the core study with no significant safety concerns
Who cannot join
- Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
- Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
- Diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alpin Research Center
Boulder, Colorado, 80304
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
University of Texas Southwestern
Dallas, Texas, 75390
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, 60007
Sunrise Clinical Research, Inc.
Hollywood, Florida, 33021
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Volunteer Research Group
Knoxville, Tennessee, 37920
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
About this study
Official title: An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106.
This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
- Conditions
- Alzheimer Disease
- Being tested
- CAD106
- 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
| Study group | Role | What they receive |
|---|---|---|
| CAD106 | Experimental | Not described Receives: Biological: CAD106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.
Measured: 66 weeks
Secondary outcomes (3)
Collect long-term safety information through SAE's collection for two years after completion of the extension study.
Measured: 2 years
Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66.
Measured: 66 weeks
Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.
Measured: 66 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2012
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023685
- Sponsor's protocol ID
- CCAD106A2202E1
- Status last verified
- Jun 2013
- First submitted
- 1 Dec 2009
- Last updated
- 17 Dec 2020
- Results posted
- No
Publications
Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.
PubMed 25918556
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106.
- ClinicalTrials.gov ID
- NCT01023685
- Acronym / sponsor ID
- CCAD106A2202E1
- Conditions
- Alzheimer Disease
- Keywords
- Active immunization, Alzheimer disease, Antibody, Central Nervous System diseases, Neurodegenerative diseases, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Dec 2009 (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 investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAD106 | Experimental | Biological: CAD106 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have completed the core study with no significant safety concerns
Key exclusion criteria (4 listed)
- Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
- Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
- Diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| CAD106 | Biological | CAD106 |
Primary outcome
Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.
Time frame: 66 weeks
3 secondary outcomes
Collect long-term safety information through SAE's collection for two years after completion of the extension study.
Time frame: 2 years
Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66.
Time frame: 66 weeks
Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.
Time frame: 66 weeks
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 17 Dec 2020.
- Derived from this study: PubMed 25918556Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.
- Results for CCAD106A2202E1 from the Novartis Clinical Trials 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAD106 in people with Alzheimer Disease, run by Novartis at 8 sites in United States.
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 1 inclusion and 4 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 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/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66. (time frame: 66 weeks). 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 NCT01023685, 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 17 Dec 2020.