Phase
Condition
Mild Cognitive Impairment
Dementia
Multiple Sclerosis
Treatment
LY3954068
Placebo
Flortaucipir F18
Clinical Study ID
Ages 50-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m²), inclusive, at screening.
Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant.
Have a mini mental state examination (MMSE) score of 18 to 30 at screening.
Have a clinical dementia rating (CDR) global score of 0.5 to 1.0, with a memory boxscore ≥ 0.5 at screening.
Meet flortaucipir F18 positron emission tomography (PET) criteria, as defined in theTAUVID™ FDA label (TAUVID™ prescribing information, 2024), demonstrating evidence oftau pathology.
Males who agree to follow contraceptive requirements, or women not of childbearingpotential (WNOCBP).
Participants must have up to 2 study partners who are with contact with theparticipant at least 10 hours per week and one of whom can attend studyappointments.
Exclusion
Exclusion Criteria:
Has current serious or unstable illnesses including cardiovascular, hepatic, renal,gastroenterological, respiratory, endocrinologic, neurologic (other than Alzheimer'sDisease), psychiatric, immunologic, or hematologic disease and other conditionsthat, in the investigator's opinion, could interfere with the analyses in thisstudy; or has a life expectancy of less than (<)24 months.
Have a sensitivity to flortaucipir F18.
Have contraindication to magnetic resonance imaging (MRI), including claustrophobiaor the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
Have a current exposure to an amyloid targeted therapy (ATT). Prior exposure to ATTsgreater than 1 year from the last dose may be permitted at the discretion of theinvestigator and in consultation with the sponsor.
Have previous exposure to any Investigational Medicinal Product administeredintrathecal (IT) or previous exposure to any anti-tau therapy.
Have a history of clinically significant back pain, back pathology and/or backinjury (for example, degenerative disease, spinal deformity or spinal surgery) thatmay predispose to complications or technical difficulty with lumbar puncture.
Study Design
Connect with a study center
The University of Tokyo Hospital
Bunkyo-ku, Tokyo 113-8655
JapanSite Not Available
The University of Tokyo Hospital
Bunkyō City, 113-8655
JapanActive - Recruiting
The University of Tokyo Hospital
Bunkyō City 11790632, 113-8655
JapanSite Not Available
National Hospital for Neurology and Neurosurgery (UCLH)
London, WC1N 3BG
United KingdomActive - Recruiting
University College London Hospitals NHS Foundation Trust - National Hospital for Neurology & Neurosurgery
London, WC1N 3BG
United KingdomSite Not Available
National Hospital for Neurology and Neurosurgery (UCLH)
London 2643743, WC1N 3BG
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield, S10 2JF
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield 2638077, S10 2JF
United KingdomSite Not Available
University Hospital Southampton
Southampton, SO16 6YD
United KingdomSite Not Available
University Hospital Southampton
Southampton 2637487, SO16 6YD
United KingdomSite Not Available
K2 Medical Research LLC
Maitland, Florida 32751
United StatesSite Not Available
K2 Medical Research, LLC
Maitland, Florida 32751
United StatesActive - Recruiting
Progressive Medical Research
Port Orange, Florida 32127
United StatesSite Not Available
Charter Research, LLC
The Villages, Florida 32162
United StatesActive - Recruiting
K2 Medical Research, LLC
Maitland 4163220, Florida 4155751 32751
United StatesSite Not Available
Charter Research, LLC
The Villages 4175179, Florida 4155751 32162
United StatesSite Not Available
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia 30030
United StatesActive - Recruiting
CenExel iResearch, LLC (CenExel iRA)
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Indiana University School of Medicine
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University School of Medicine - Clinical Research Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Harvard Medical School - Massachusetts General Hospital (MGH) - Neurological Associates
Boston, Massachusetts 02114-2117
United StatesSite Not Available
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts 02129
United StatesSite Not Available
Massachusetts General Hospital (MGH)
Charlestown 4932819, Massachusetts 6254926 02129
United StatesSite Not Available
CenExel-HRI
Marlton, New Jersey 08053
United StatesSite Not Available
CenExel AMRI
Toms River, New Jersey 08755
United StatesActive - Recruiting
CenExel AMRI
Toms River 4504476, New Jersey 5101760 08755
United StatesSite Not Available
Duke University
Durham, North Carolina 27710
United StatesActive - Recruiting
Duke University
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available

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