Alzheimer's DiseasePhase 2NCT00795418
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
A Phase 2 study testing CAD106 in people with Alzheimer's Disease, run by Novartis at 10 sites in United States.
Trial summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CAD106
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2008to Nov 2010
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female patients between 40 and 85 years of age (both inclusive)
- Diagnosis of mild Alzheimer's Disease (AD)
- Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks.
Who cannot join
- Previously participated in an AD vaccine study and received active treatment.
- History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
- History or presence of seizures 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 of the patient.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Alpine Clinical Research Center
Boulder, Colorado, 80304
ATP Clinical Research
Costa Mesa, California, 92626
University of Texas Southwestern
Dallas, Texas, 75390-9139
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, 60007
Sunrise Clinical Research
Hollywood, Florida, 33021
Indiana University School of Medicine
Indianapolis, Indiana, 46202
NOCCR Knoxville
Knoxville, Tennessee, 37920
MidAmerica NeuroScience Research Foundation
Lenexa, Kansas, 66214
Columbia University Medical Center
New York, New York, 10032
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
About this study
Official title: A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease
- Conditions
- Alzheimer's Disease
- Being tested
- Placebo, CAD106
- Keywords
- Active immunization, Alzheimer's disease, Antibody, Vaccine, Central Nervous System Diseases, Neurodegenerative diseases
- 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.
PlaceboBiological
Placebo comparator
CAD106Biological
| Study group | Role | What they receive |
|---|---|---|
| CAD106 | Experimental | Not described Receives: Biological: CAD106 |
| Placebo | 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/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)
Measured: 52 weeks
Secondary outcomes (3)
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Measured: 52 weeks
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Measured: 52 weeks
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 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
- NCT00795418
- Sponsor's protocol ID
- CCAD106A2202
- Status last verified
- May 2012
- First submitted
- 10 Nov 2008
- 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
- A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
- ClinicalTrials.gov ID
- NCT00795418
- Acronym / sponsor ID
- CCAD106A2202
- Conditions
- Alzheimer's Disease
- Keywords
- Active immunization, Alzheimer's disease, Antibody, Vaccine, Central Nervous System Diseases, Neurodegenerative diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2010 (actual)
- First posted
- 21 Nov 2008 (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 evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid 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
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD106 | Experimental | Biological: CAD106 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and/or female patients between 40 and 85 years of age (both inclusive)
- Diagnosis of mild Alzheimer's Disease (AD)
- Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks.
Key exclusion criteria (6 listed)
- Previously participated in an AD vaccine study and received active treatment.
- History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
- History or presence of seizures 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 of the patient.
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 |
|---|---|---|
| PlaceboPlacebo comparator | Biological | Placebo |
| CAD106 | Biological | CAD106 |
Primary outcome
Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)
Time frame: 52 weeks
3 secondary outcomes
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time frame: 52 weeks
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time frame: 52 weeks
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time frame: 52 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 CCAD106A2202 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
10 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's Disease, run by Novartis at 10 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 3 inclusion and 6 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 10 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. 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/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI) (time frame: 52 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 NCT00795418, 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.