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ACC-001

Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Johnson & Johnson|Last Updated: Jan 5, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment126
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01284387Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's DiseasePHASE2 COMPLETED 126Jan 1, 2011Feb 1, 2014Jan 5, 201525 United States
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Study Endpoints
Primary Endpoints
To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease.
24 Months
Secondary Endpoints
To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity.
24 Months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
3 μg ACC-001 / QS-21 50 μg IM dose 1EXPERIMENTAL3 μg ACC-001 / QS-21 50 μg IM
10 μg ACC-001 / QS-21 50 μg IM dose 2EXPERIMENTAL10 μg ACC-001 / QS-21 50 μg IM
Placebo - Phosphate buffered saline (PBS) IM doseNO_INTERVENTIONPlacebo - Phosphate buffered saline (PBS) IM
Interventions
NameTypeDescription
ACC-001 (vanutide cridificar)BIOLOGICALComparisons of 2 different doses of ACC-001 or placebo for 24 months
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Eligibility Criteria
Age Range50 Years — 89 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Diagnosis of probable AD * Age from 50 to 89 * Mini-Mental Status Exam score of 18-26 inclusive * Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD * Stable doses of medications (cholinesterase inhibitors and memantine allowed) * Caregiver able to...

Countries:United States
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