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Phase 3 IGIV, 10% in Alzheimer´s Disease

Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer´s Disease

Intervention: Immune Globulin Intravenous (Human), 10% Solution (Biological); Human albumin 0.25% (Biological)

Phase: Phase 3

Status: Terminated

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Kathy Tobias, MD, Study Director, Affiliation: Baxter Healthcare Corporation

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.

Clinical Details

Official title: A Phase 3 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) for the Treatment of Mild to Moderate Alzheimer's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)

Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory

Secondary outcome:

ADCS-Clinical Global Impression of Change (CGIC) at 18 Months

Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)

Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement

Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)

Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)

Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

Number of Participants Experiencing Any AEs and/or SAEs

Number of Infusions Temporally Associated With AEs and/or SAEs

Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion

Number of Infusions Causally Associated With AEs and/or SAEs

Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE

Eligibility

Minimum age: 50 Years. Maximum age: 89 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

- Uncontrolled seizure disorder as defined by two or more breakthrough seizures per

year despite adequate antiepileptic drug (AED) treatment

- Modified Hachinski score > 4 at time of screening

- Subjects with 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

- Active autoimmune or neuro-immunologic disorder

- Uncontrolled major depression, psychosis, or other major psychiatric disorder(s)

- Poorly controlled diabetes, defined as glycosylated (or glycated) hemoglobin (HbA1c)

≥ 6. 5% at screening

- Creatinine clearance < 50% of normal adjusted for age and gender, as calculated

according to the Cockcroft-Gault formula, at the time of screening

- Known history of untreated vitamin B12 deficiency within 6 months prior to screening,

or clinically significant abnormally low vitamin B12 at the time of screening

- Abnormal clinical chemistry panel or hematology panel meeting any one of the

following criteria:

- Serum alanine aminotransferase (ALT) > 2. 5 x upper limit of normal (ULN)

- Clinically significant anemia that precludes repeated blood sampling or hemoglobin

(Hgb) < 10. 0 g/dL

- Absolute neutrophil count (ANC) < 1000 cells/µL

- Known coagulopathy or platelet counts < 100,000 cells/µL

- Total serum protein > 9 g/dL

- Known history of or positive serology at screening for one or more of the following:

hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) type 1/2 antibody

- Immunoglobulin A (IgA) deficiency (< 8 mg/dL)

- Known history of hypersensitivity following infusions of human blood or blood

components (e. g. human immunoglobulins or human albumin)

- Currently receiving or has received: anti-CD20 therapy within 12 months prior to

screening, or other immunomodulatory therapies (e. g. anti-TNF, anti-IL-1, interferon) within 12 weeks prior to screening. The following exceptions are allowed: non-systemic corticosteroids (eg, topical, opthalmic or inhaled glucocorticoids) and low-dose systemic corticosteroids (prednisone < 10 mg/day or its equivalent)

- Currently receiving or has received intravenous or subcutaneous immunoglobulin

treatment within the 2 years prior to screening, or has received immunoglobulin in Baxter Protocol 160701

- Currently receiving or has received at any time active immunization aimed at

modulating AD progression

- Currently receiving or has received within 12 months prior to screening any

investigational device, drug or biologic (eg passive immunotherapies with monoclonal or polyclonal antibodies) aimed at modulating AD progression

- Subject has been exposed to an investigational product (IP) or investigational device

within 12 weeks prior to screening or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

- Subject is a family member or employee of the investigator

- The subject is nursing or intends to begin nursing during the course of the study

- Any disorder or disease, or clinically significant abnormality on laboratory or other

clinical test(s) (eg, blood tests, urine tests, electrocardiogram, chest x-ray), that in medical judgment may impede the subject's participation in the study, pose increased risk to the subject, or confound the results of the study

- Currently receiving anti-coagulant agent and/or anti-platelet agent other than

acetylsalicylic acid (a. k.a. aspirin)

Locations and Contacts

Edegem, Belgium

Gent, Belgium

Hasselt, Belgium

Leuven, Belgium

Roeselare, Belgium

Akashi, Japan

Akita, Japan

Azumino, Japan

Chiba, Japan

Fukui, Japan

Kyoto, Japan

Niigata, Japan

Osaka, Japan

Saga, Japan

Tokushima, Japan

Tokyo, Japan

Lublin, Poland

Scinawa, Poland

Warszawa, Poland

Barcelona, Spain

Madrid, Spain

Valencia, Spain

Bath, United Kingdom

Brentford, United Kingdom

Brighton, United Kingdom

Glasgow, United Kingdom

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Long Beach, California, United States

San Diego, California, United States

Santa Ana, California, United States

Uckfield, East Sussex, United Kingdom

Boca Raton, Florida, United States

Delray Beach, Florida, United States

Edgewater, Florida, United States

Orlando, Florida, United States

Decatur, Georgia, United States

Chicago, Illinois, United States

Springfield, Illinois, United States

Paducah, Kentucky, United States

St. Paul, Minnesota, United States

Olive Branch, Mississippi, United States

Las Vegas, Nevada, United States

Berlin, New Jersey, United States

Chester, New Jersey, United States

Eatontown, New Jersey, United States

Summit, New Jersey, United States

Toms River, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Latham, New York, United States

Manhasset, New York, United States

New Hyde Park, New York, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Toronto, Ontario, Canada

Greenfield Park, Quebec, Canada

Sherbrooke, Quebec, Canada

Providence, Rhode Island, United States

Woodville South, South Australia, Australia

Austin, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Bennington, Vermont, United States

Charlottesville, Virginia, United States

Cruces-Barakaldo, Vizcaya, Spain

Milwaukee, Wisconsin, United States

Additional Information

Starting date: January 2012
Last updated: June 26, 2015

Page last updated: August 23, 2015

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