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Phase 3 IGIV, 10% in Alzheimer´s Disease

NCT01524887 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2021-05-19

Study results available
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Summary

The purpose of this study is to provide evidence of efficacy and safety to support the development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s Disease.

Conditions

  • Alzheimer´s Disease

Interventions

BIOLOGICAL

Immune Globulin Intravenous (Human), 10% Solution

Intravenous infusion every 2 weeks over 18 months

BIOLOGICAL

Human albumin 0.25%

Intravenous infusion every 2 weeks over 18 months

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-23
Primary Completion
2013-07-16
Completion
2013-07-16

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Japan
  • Poland
  • Spain
  • United Kingdom

Study Locations

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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 NCT01524887 on ClinicalTrials.gov