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Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients

NCT01097096 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2021-03-05

No results posted yet for this study

Summary

This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.

Conditions

Interventions

BIOLOGICAL

CAD106

150μg and 450μg doses were reconstituted and administered via intramuscular injection

BIOLOGICAL

Placebo

Identical placebo to CAD106 administered via intramuscular injection

BIOLOGICAL

Alum

An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106

BIOLOGICAL

MF59

An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01097096 on ClinicalTrials.gov