NL-OMON49765
Withdrawn
Phase 2
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease - M15-570
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- neurologisch
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Enrollment
- 7
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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\.
Outcomes
Primary Outcomes
Not specified
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