Phase
Condition
Memory Loss
Dementia
Mental Disability
Treatment
Flutemetamol F18 Injection
[18F]-MK-6240 Injection
[18F]-RO6958948 Injection
Clinical Study ID
Ages 50-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Individuals between the ages of 50 and 80 years old (inclusive)
Score of 16 or above on the MoCA telephone
Score of 27 or greater on the MMSE for individuals aged 50 to 64 years old or ascore of 26 or greater for individuals aged 65 to 80 years old
Participants in the 50-60 age range will additionally need to meet at least one ofthe following: (1) First degree family history of dementia with onset before age 75; (2) APOE e4 allele carrier; or (3) Prior elevated result on amyloid PET or amyloidCSF testing
Conversationally fluent in English to the extent that an interpreter is notnecessary for comprehension of the study information, procedures, and cognitivetests.
If participants elect to participate in the optional disclosure procedure, they willbe required to have an appropriate study partner who agrees to participate in thestudy and who is intellectually, visually, and auditory capable, andconversationally fluent in English to the extent that an interpreter is notnecessary.
Adequate visual and auditory acuity to allow neuropsychological testing.
Participants must be willing and able to provide written informed consent.
Exclusion
Exclusion Criteria:
Diagnosis of mild cognitive impairment or dementia
History of significant brain injury or other known neurologic disease or insult,resulting in lasting cognitive sequelae that would confound the assessment andstaging of potential neurodegenerative disease (e.g., Huntington's disease,Parkinson's disease, Parkinsonism due to multiple system atrophy (MSA), progressivesupranuclear palsy (PSP), Shy Drager Syndrome (SDS) or other neuro-degenerativedementias, encephalitis or other brain infection, epilepsy or stroke with lastingimpairment to cognitive function).
Current serious or unstable systemic illness or organ failure that, in the PI'sjudgement, would make it difficult to participate in the study (e.g., such asterminal cancer, cardiovascular, hepatic, renal, gastroenterological, respiratory,endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease orother conditions ). History of cancer is acceptable with at least one year inremission with a good prognosis.
Individuals with clinically significant depression, bipolar disorder, anxiety, orsuicidal ideations within the past year as defined by the most current version ofthe Diagnostic and Statistical Manual of Mental Disorders (DSM).
A history of schizophrenia as defined by the most current version of the DSM.
History within the past year of chronic alcohol or drug abuse/dependence as definedby the most current version of the DSM.
Marijuana use is acceptable, but frequent users will be asked to abstain from usewithin 24 hours of any assessments.
Refusing or unable to complete any study procedures.
Currently enrolled in another study which involves clinical drug trial or othermedical intervention.
Study Design
Connect with a study center
Butler Hospital Memory and Aging Program
Providence, Rhode Island 02906
United StatesSite Not Available
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