Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
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ClinicalTrials.gov Identifier: NCT00733863 |
Recruitment Status :
Completed
First Posted : August 13, 2008
Last Update Posted : February 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Biological: Placebo Biological: CAD106 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: CAD106 |
Placebo Comparator: 2 |
Biological: Placebo |
- Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. [ Time Frame: 52 weeks ]
- Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52. [ Time Frame: 52 weeks ]

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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Mild Alzheimer's Disease
- 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
Exclusion Criteria:
- 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 an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733863
France | |
Centre Hospitalier Universitaire Pellegrin | |
Bordeaux, France | |
Sweden | |
Karolinska Universitetssjukhuset Huddinge | |
Stockholm, Sweden | |
Switzerland | |
NeuroPsychologieZentrum | |
Basel, Switzerland | |
United Kingdom | |
Moorgreen Hospital | |
Southampton, United Kingdom |
Principal Investigator: | Novartis Pharmaceuticals | Novartis |
Responsible Party: | External Affairs, Novartis |
ClinicalTrials.gov Identifier: | NCT00733863 |
Other Study ID Numbers: |
CCAD106A2201 |
First Posted: | August 13, 2008 Key Record Dates |
Last Update Posted: | February 11, 2020 |
Last Verified: | May 2010 |
Active immunization Alzheimer disease Antibody |
Central Nervous System Diseases Neurodegenerative diseases Vaccine |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |