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

Baxalta now part of Shire0 sites508 target enrollmentJanuary 23, 2012

ConditionsAlzheimer´s Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Alzheimer´s Disease
Sponsor: Baxalta now part of Shire
Enrollment: 508
Primary Endpoint: Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 23, 2012

End Date

July 16, 2013

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxalta now part of Shire

Responsible Party

Sponsor

Eligibility 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

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)

Outcomes

Primary Outcomes

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

Time Frame: Baseline to 9 Months (actual time frame)

The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.

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

Time Frame: Baseline to 9 Months (actual time frame)

The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration.

Secondary Outcomes

Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)(Baseline to 9 Months (actual time frame))
ADCS-Clinical Global Impression of Change (CGIC) at 18 Months(Baseline to 9 Months (actual time frame))
Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE(Throughout infusions, approximately 2-5 hours)
Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)(Baseline to 9 Months (actual time frame))
Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement(Baseline to 9 Months (actual time frame))
Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)(Baseline to 9 Months (actual time frame))
Number of Participants Experiencing Any AEs and/or SAEs(Throughout the study period: 18 Months)
Number of Infusions Temporally Associated With AEs and/or SAEs(During or within 72 hours of completion of an infusion)
Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion(During or within 7 days of completion of an infusion)
Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)(Throughout the study period: 18 Months)
Number of Infusions Causally Associated With AEs and/or SAEs(Throughout the study period: 18 Months)