Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

Phase 2 Completed 63 enrolled Pfizer JANSSEN Alzheimer Immunotherapy Research & Development, LLC · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Timeline

Start: 2011-02
Primary completion: 2014-02
Completion: 2014-02

Outcome

Missed primary endpoint

registry Overall ACC + QS21 vs Placebo; p = 0.9544; Mean Difference (Final Values) 0.002 (95% CI -0.062 to 0.066) NCT01227564 ↗

paper At week 104, no significant differences were observed in 18F-florbetapir positron emission tomography composite cortical standard uptake value ratio between either ACC-001 dose compared with placebo. PMID 29210443 ↗

Publications

van Dyck CH, Sadowsky C, Le Prince Leterme G, Booth K, Peng Y, Marek K, Ketter N, Liu E, Wyman BT, Jackson N, Slomkowski M, Ryan JM. Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Individuals with Early Alzheimer's Disease: Amyloid Imaging Positron Emission Tomography and Safety Results from a Phase 2 Study. J Prev Alzheimers Dis. 2016;3(2):75-84. doi: 10.14283/jpad.2016.91.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vanutide Cridificar	Vaccine	3 ug	Intramuscular
Subject	Vanutide Cridificar	Vaccine	10 ug	Intramuscular
Background	QS-21	Other / unclassified	50 ug	Intramuscular