Phase
Condition
N/ATreatment
Placebo
LY4006895
Clinical Study ID
Ages 45-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for Part A and Part B:
Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study
Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²)
For Part A:
Have early symptomatic AD, as defined by:
Gradual and progressive change in memory function for at least 6 months, as reported by the participant or informant
A Mini-Mental State Exam (MMSE) score of 18 to 30 at screening
A Clinical Dementia Rating (CDR) global score of 0.5 to 1.0 (inclusive), with a memory box score greater than or equal to 0.5 at screening
For Part B:
- Have up to 2 reliable study partners who are in frequent contact with the participant (defined as at least 10 hours per week), one of whom at any one occasion: will accompany the participant to the study visits, will be available by telephone at designated times, and will provide a separate written informed consent to participate
Exclusion Criteria for Part A and Part B:
Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (MAD: other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the participant's ability to complete the study; or has a life expectancy of less than 24 months
Have screening hemoglobin (Hb) less than 12 grams per deciliter (g/dL) or evidence of iron-deficiency (ferritin less than 30 nanograms per milliliter (ng/mL), or presence/history of hemoglobinopathy
Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening that cannot be explained by regular concomitant medications
Have previous exposure to any anti-tau therapy
Are pregnant or intend to become pregnant or to breastfeed during the study
For Part B:
Have a current exposure to an amyloid targeted therapy. Prior exposure to amyloid targeted therapies greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor. A listing of amyloid targeted therapies will be provided
Have a sensitivity to florataucipir 18F
Have contraindication to magnetic resonance imaging (MRI) including claustrophobia or the presence of contraindicated metal (ferrogmagnetic) implants/cardiac pacememaker
Study Design
Connect with a study center
Collaborative Neuroscience Network - CNS
Los Alamitos, California 90720
United StatesSite Not Available
PRIM: CenExel - CNS
Los Alamitos, California 90720
United StatesSite Not Available
Collaborative Neuroscience Network - CNS
Los Alamitos 5368304, California 5332921 90720
United StatesActive - Recruiting
K2 Medical Research - The Villages
Lady Lake, Florida 32159
United StatesSite Not Available
K2 Medical Research
Maitland, Florida 32751
United StatesSite Not Available
K2 Medical Research - The Villages
Lady Lake 4161118, Florida 4155751 32159
United StatesSite Not Available
K2 Medical Research
Maitland 4163220, Florida 4155751 32751
United StatesSite Not Available
Atlanta Center of Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia 30030
United StatesSite Not Available
Atlanta Center of Medical Research
Atlanta 4180439, Georgia 4197000 30331
United StatesSite Not Available
CenExel iResearch, LLC (CenExel iRA)
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
CenExel-HRI
Marlton, New Jersey 08053
United StatesSite Not Available
CenExel-HRI
Marlton 4502911, New Jersey 5101760 08053
United StatesSite Not Available
Duke Early Phase Research Unit
Durham, North Carolina 27710
United StatesSite Not Available
Duke Early Phase Research Unit
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
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