An extension study to continue evaluating the long-term safety and tolerability of ABBV-8E12 in subjects with early Alzheimer's disease

Phase 1

• Conditions: Alzheimer's Disease; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-000268-26-ES
• Lead Sponsor: AbbVie Deutschland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Subject has voluntarily provided written informed consent
Subject completed the 96-week treatment period of Study M15-566.
Subject has an identified, reliable study partner who has frequent contact with the subject and who will provide information as to the subject's cognitive and functional abilities.
The study partner has provided written informed consent.
If female, subject must be postmenopausal or permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
If the male subject is sexually active with female partner(s) of childbearing potential, he must agree, from Study Day 1 through 20 weeks after the last dose of study drug to practice the protocol specified contraception and must refrain from sperm donation.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

Subject has any significant change in his/her medical condition since participation in Study M15-566 that could interfere with the subject's participation in Study M15-570, could place the subject at increased risk, or could confound interpretation of study results. This would include any clinically significant neurological, hematological, autoimmune, endocrine, cardiovascular, neoplastic, renal, hepatic, metabolic, psychiatric, pulmonary, gastrointestinal, or other major disorder or contraindication to or inability to tolerate brain MRI or PET scans.

More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-566.

Subject is concurrently enrolled in another interventional clinical study (with the exception of Study M15-566) involving a therapeutic agent.

Subject is considered by the investigator to be an unsuitable candidate to receive ABBV-8E12 or the subject is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations.

Study & Design

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