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

• Results First Posted: 1900-01-01
• Study Start: 2015-05-19
• Last Update Posted: 13 January 2020

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

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to test the impact of solanezumab, administered as an intravenous infusion at a dose of 400 mg every 4 weeks for 3 years, on cognition as compared with placebo in subjects with preclinical AD using MMRM analysis of the Cognitive Function Index (CFI) .[168 weeks]

Secondary Outcome Measures

Name	Time	Method
To test the impact of solanezumab on cognition and performance of everyday activities, as compared with placebo using the Preclinical Alzheimer's Cognitive Composite (PACC).[168 weeks.];To assess whether decline in activities of daily living begins by the end of the treatment period, and if so,whether an effect of solanezumab, compared with placebo, can be detected using MMRM analysis of the ADCS-Activities of Daily Living (ADCS-ADL) Prevention Questionnaire.<br>[168 weeks];To measure the effect of solanezumab on brain amyloid burden, as compared with placebo, as assessed using florbetapir PET imaging.<br>[168 weeks];To investigate the effect of treatment with solanezumab on volumetric magnetic resonance imaging<br>(MRI).[168 weeks];Chest pain (1.1%), Slowing of heart rate (0.8%), Itchy rash, fainting, heart problems, brain swelling (1%), small bleeds in the brain (9%).<br><br>Immunogenicity data (anti-solanezumab) after treatment will be compared between the treatment groups.[168 weeks]