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Clinical Trials List

Protocol Number221AD304
NCT Number(ClinicalTrials.gov Identfier)NCT04241068

2020-05-18 - 2023-12-31

Others

Not yet recruiting3

Recruiting2

ICD-10G30.0

Alzheimer's disease with early onset

ICD-10G30.1

Alzheimer's disease with late onset

ICD-10G30.8

Other Alzheimer's disease

ICD-10G30.9

Alzheimer's disease, unspecified

ICD-9331.0

Alzheimer's disease

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects With Alzheimer’s Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302, and 221AD205

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Biogen

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Ming-Chyi Pai Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 王文甫 Division of Neurology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chin-Chang Huang Division of Neurology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張瓊之 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Pei-Ning Wang Division of Neurology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Alzheimer's Disease

Objectives

The primary objective is to evaluate the long-term safety and tolerability of aducanumab after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).

Test Drug

Aducanumab

Active Ingredient

Aducanumab

Dosage Form

Concentrate for solution for infusion

Dosage

100mg/mL

Endpoints

1.Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) .
2.Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal .
3.Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E) .
4.Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H).
5.Number of Participants With Antidrug Antibodies (ADAs) in Serum.

Inclution Criteria

1.Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies).
2.Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.

Exclusion Criteria

1.Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment.
2.Stroke or any unexplained loss of consciousness within 1 year prior to Screening.
3.Clinically significant unstable psychiatric illness in past 6 months.
4.History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.
5.A seizure event that occurred after the last visit of the feeder study and before Screening for this study.
6.Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.
7.History of or known seropositivity for HIV.
8.Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.
9.Contraindications to having a brain magnetic resonance imaging (MRI).

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    2400 participants

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