The Anti-Amyloid Treatment in Asymptomatic Alzheimer's disease study - the A4 study

Phase 3

Recruiting

• Conditions: Alzheimer's Disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12615000500550
• Lead Sponsor: The FIL Foundation (FIL Investment Management Limited)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-19
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

[1]Male or female ages 65 to 85 years old.
[2] Has an MMSE score at screening of 25 to 30.
[3] Has a global CDR score at screening of 0.
[4] Has a Logical Memory II score at screening of 6 to 18.
[5] Has a florbetapir PET scan that shows evidence of brain amyloid pathology at
Visit 2.
[6] In general, permitted medications should be stable for 6 weeks prior to baseline (visit 6)

Exclusion Criteria

[1] Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening (Visit 1) or baseline (Visit 6).
[2] Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded.
[3] Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric,
immunologic, or hematologic disease or other conditions that, in the investigator’s opinion, could interfere with the analyses of safety and efficacy in this study.
[4] Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness.
[5] Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen posttreatment.
[6] Has allergies to humanized monoclonal antibodies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified