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Long-Term Study of IGIV, 10% in Alzheimer´s Disease

NCT01736579 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-05-19

Study results available
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Summary

The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.

Conditions

  • Alzheimer´s Disease

Interventions

DRUG

Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-29
Primary Completion
2013-06-04
Completion
2013-06-04

Countries

  • United States

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 NCT01736579 on ClinicalTrials.gov