A Phase 2 Multiple Dose Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease
M
Martin Farlow, MD
Primary Investigator
Overview
In this research study we are testing a new drug called ABBV-8E12 to see if it is safe and if it can slow down Alzheimer?s disease when recognized very early.
Description
The purpose of this study is to test a new drug called ABBV-8E12 to see if it is safe and if it can slow down Alzheimer's disease when recognized very early.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Alzheimer's disease
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Age: Between 55 Years - 85 Years
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Gender: All
Inclusion Criteria
Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD
Has a positive amyloid Positron Emission Tomography (PET) scan
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
If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization
Exclusion Criteria
Any visual, auditory or other impairments that in the Investigator's opinion would preclude collection of outcome measures
Any contraindication to or inability to tolerate brain MRIs
Any contraindication to or inability to tolerate a PET scan
Any contraindication too or inability to tolerate lumbar punctures
Has evidence of any other clinically significant neurological disorder other than Early AD
Has a screening MRI scan, interpreted by a radiologist with evidence of infection, infarction, or other focal lesions
Has a history of or currently has schizophrenia, schizoaffective disorder, or bipolar disorder
Has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening Visit 1
Has a history or evidence of a malignancy within the 2 years prior to Screening Visit 1
Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody or known history of HIV infection
Has had surgery under general anesthesia within 3 months prior to Screening or has a planned major surgical procedure scheduled during the period when the subject would be participating in the study
Receipt of an investigational product within a time period equal to 5 half-lives, if known, or within 6 weeks (for small molecules) or 6 months (for monoclonal antibodies or other biologics) prior to study drug administration
Any history of prior receipt of active immunotherapy directed against tau or amyloid
Additional Information:Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD
Has a positive amyloid Positron Emission Tomography (PET) scan
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
If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization
Exclusion Criteria
Any visual, auditory or other impairments that in the Investigator's opinion would preclude collection of outcome measures
Any contraindication to or inability to tolerate brain MRIs
Any contraindication to or inability to tolerate a PET scan
Any contraindication too or inability to tolerate lumbar punctures
Has evidence of any other clinically significant neurological disorder other than Early AD
Has a screening MRI scan, interpreted by a radiologist with evidence of infection, infarction, or other focal lesions
Has a history of or currently has schizophrenia, schizoaffective disorder, or bipolar disorder
Has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening Visit 1
Has a history or evidence of a malignancy within the 2 years prior to Screening Visit 1
Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody or known history of HIV infection
Has had surgery under general anesthesia within 3 months prior to Screening or has a planned major surgical procedure scheduled during the period when the subject would be participating in the study
Receipt of an investigational product within a time period equal to 5 half-lives, if known, or within 6 weeks (for small molecules) or 6 months (for monoclonal antibodies or other biologics) prior to study drug administration
Any history of prior receipt of active immunotherapy directed against tau or amyloid
Participants will be paid for their participation.
Updated on
20 Apr 2024.
Study ID: 1611117291
