221AD301 Phase 3 Study of Aducanumab in Early Alzheimer's Disease

Phase 1

• Conditions: Early Alzheimer's Disease; MedDRA version: 18.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-000966-72-ES
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-10
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1350

Inclusion Criteria

Key Inclusion Criteria:
- Must meet all of the following clinical criteria for MCI due to AD or mild
AD and must have:
- A Clinical Dementia Rating (CDR)-Global Score of 0.5.
- A Repeatable Battery for Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment
- An MMSE score between 24 and 30 (inclusive)
- Must have a positive amyloid Positron Emission Tomography (PET)
scan
- Must consent to apolipoprotein E (ApoE) genotyping
- Must have stable symptomatic AD medications
- Must have a reliable informant or caregiver

LTE specific Criteria at week 78:
- Must have completed the placebo-controlled period of the study.
- MMSE score > 15 at the Week 78 Visit.
- Must (or the subject?s legally authorized representative) understand the purpose and risks of the study and provide signed consent (or assent)
- Apart from a clinical diagnosis of AD, subject must be in good health as determined by the Investigator, based on medical history.
- Must have the ability to comply with procedures for protocol-related tests.
- Must have reliable informant or caregiver

NOTE: Other protocol defined Inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

Exclusion Criteria

Key Exclusion Criteria:
- Any medical or neurological condition (other than Alzheimer's Disease)
that might be a contributing cause of the subject's cognitive impairment
- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained
loss of consciousness in the past 1 year
- Clinically significant psychiatric illness in past 6 months
- History of unstable angina, myocardial infarction, chronic heart failure,
or clinical significant conduction abnormalities within 1 year prior to Screening
- Indication of impaired renal or liver function
- Have human immunodeficiency virus (HIV) infection
- Have a significant systematic illness or infection in past 30 days
- Relevant brain haemorrhage, bleeding disorder and cardiovascular abnormalities
- Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
- Alcohol or substance abuse in past 1 year
- Taking blood thinners (except for aspirin at a prophylactic dose or less)
- Use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1

Subjects will be excluded from entering the LTE if at Week 78 they have:
- any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the subject's participation in the study.

NOTE: Other protocol defined Exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified