Phase 3 IGIV, 10% in Alzheimer´s Disease

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Alzheimer´s Disease

In brief

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.

Key facts

Study ID

NCT01524887

Run by

Baxalta now part of Shire

People needed

508

Starts

2012-01-23

Expected to finish

2013-07-16

Last updated by the study team

2021-05-19

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females of age 50 to 89 years inclusive at the time of screening
• Written informed consent obtained from either the subject or the subject's legally authorized representative prior to any study-related procedures
• Written informed consent obtained from an able and competent caregiver who is willing to comply with the requirements of the protocol pertaining to him/her, including facilitating the subject's participation in the study
• Diagnosis of Probable Alzheimer´s Disease (AD) according to NINCDS-ADRDA* 1984 criteria (* National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association)
• Dementia of mild to moderate severity (Mini-Mental State Examination [MMSE] 16-26 inclusive at the time of screening)
• Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis
• Willingness to comply with the requirements of the protocol and ability to comply with testing and infusion regimen, including adequate corrected visual acuity and hearing ability
• For at least 12 weeks prior to screening, on stable doses of AD medication(s) approved by local regulatory authorities. Subjects must not be on two acetylcholinesterase inhibitors concurrently.
• Venous access for repeated infusion and phlebotomy
• If receiving psychoactive medications (eg, antidepressants other than monoamine oxidase inhibitors [MAOIs] and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc.), must be on stable doses for at least 6 weeks prior to screening
• For women of childbearing potential, the subject must have a negative pregnancy test at screening and must agree to employ adequate contraceptive measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study
• For subjects with a coronary artery stent, the subject must receive documented medical clearance from an interventional cardiologist stating that the subject is not at increased risk for stent occlusion with immunoglobulin treatment
• For subjects with an endovascular stent, the subject must receive documented medical clearance from a vascular surgeon stating that the subject is not at increased risk for thromboembolic events with immunoglobulin treatment
• Main Exclusion Criteria:
• Possible AD by NINCDS-ADRDA criteria or non-Alzheimer dementia (eg, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, or dementia arising from other diseases or conditions such as Parkinson's disease, vitamin B12 deficiency, thyroid abnormalities)
• Current residence in a skilled nursing facility
• Contraindication to undergoing MRI (eg, pacemaker [with the exception of an MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a metal plate)
• Clinically significant congestive heart failure (eg, New York Heart Association [NYHA] Class III/IV symptoms or untreated Class II)
• Current atrial fibrillation of unstable angina (angina at rest) or history of myocardial infarction within the 12 months prior to screening
• Uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg and/or diastolic > 100 mm Hg confirmed upon repeated measures
• History of thrombosis and/or thromboembolic disease (central or peripheral) within the 12 months prior to screening
• Known history of procoagulant abnormalities (eg, factor V Leiden, antiphospholipid syndrome, protein S/protein C deficiency, AT III deficiency)
• History of intracerebral hemorrhage within the 5 years prior to screening
• Evidence on MRI of: greater than 4 microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, prominent white matter disease with a rating score of 3 on the age-related white matter changes (ARWMC) scale from the European Task Force on ARWMC, or multiple lacunae (defined as more than 2 lacunae that are greater than 0.5 mm in size)
• Head trauma with loss of consciousness, contusion, or open head injury within the 12 months prior to screening

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Long Beach, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Boca Raton, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Edgewater, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Paducah, Kentucky, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Olive Branch, Mississippi, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Berlin, New Jersey, United States
• Study site — Chester, New Jersey, United States
• Study site — Eatontown, New Jersey, United States
• Study site — Summit, New Jersey, United States
• Study site — Toms River, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Brooklyn, New York, United States
• Study site — Latham, New York, United States
• Study site — Manhasset, New York, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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