NCT00733863CompletedPhase 2
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 27
- Locations
- 4
- Primary Endpoint
- Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
Study Overview
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
2
Placebo Comparator
Intervention: Placebo (Biological)
1
Experimental
Intervention: CAD106 (Biological)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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.(52 weeks)
Investigators
Study Sites (4)
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