TerminatedPhase 3

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

Stopped: The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.

United States6 participantsStarted 2012-11-29

Plain-language 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.

Who can participate

Age range51 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Main Inclusion Criteria: * Completed 18 months of study treatment and assessments in Baxter precursor study 160701 * Diagnosis of probable Alzheimer´s Disease (AD) * Able to comply with testing and infusion regimen (including adequate corrected visual acuity and hearing ability) * Has a caregiver (study partner) who is willing and able to participate Main Exclusion Criteria: * Significant neurological disease other than AD * Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent heart attack) * Contraindication to undergoing MRI (e.g. pacemaker \[with the exception of an MRI-compatible pacemaker\], severe claustrophobia, ferromagnetic implants such as a metal plate) * Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, or multiple lacunae) * Active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment * Uncontrolled major depression, psychosis, or other major psychiatric disorder(s) * Poorly controlled diabetes * Serious problems with liver or kidneys * Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin) * Curr…

What they're measuring

Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 6 months

Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 6 months

Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 6 months

Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)

Timeframe: 6 months

Trial details

NCT IDNCT01736579

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06-04

Results submitted2016-07-13

View on ClinicalTrials.gov More Alzheimer´s Disease trials

Plain-language summary

Who can participate

Age range51 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 6 months

Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 6 months

Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 6 months

Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)

Timeframe: 6 months