An Extension Study of ABBV-8E12 in Early Alzheimer's Disease

Phase 2

Withdrawn

Conditions: neurologisch
Alzheimer's
Alzheimer's disease

Registration Number: NL-OMON49765

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 7

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.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events, vital signs, physical examination, neurologic examination,<br /><br>electrocardiogram (ECG), laboratory tests, Columbian Suicide Severity Rating<br /><br>Scale (C-SSRS), MRI, and immunogenicity assessments.<br /><br>Timepoint of evaluation: Week 280</p><br>

Secondary Outcome Measures