FDDNP Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With S… (NCT04311281) | Clinical Trial Compass
WithdrawnNot Applicable
FDDNP Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With Suspected CTE and AD
Stopped: Insufficient Funding
0Started 2021-05
Plain-language summary
The primary objective of this study is to demonstrate the safety and efficacy of positron emission tomography (PET) imaging with a radioactive compound called \[F-18\]FDDNP in subjects with suspected Alzheimer's disease or suspected chronic traumatic encephalopathy (CTE) to predict clinical decline after one and two years.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria for all participants
Participants enrolling in the trial must meet all of the following criteria:
* Participant may be male or female and of any race/ethnicity
* Age 18 to 80 years at the time of study drug dosing
* Female participants must be either surgically sterilized or post-menopausal, defined as at least one-year without menses as reported by the participant or have a negative serum pregnancy test
* Participant or participant's legally acceptable representative (when appropriate) provides informed consent
* Participant is capable of complying with study procedures
* Participant is capable of communicating with study personnel
* Participant is willing to undergo longitudinal follow-up at 1 and 2 years after the Imaging Visit
* All participants will meet criteria for mild cognitive impairment (Petersen et al, 2014) or Mild Neurocognitive Disorder (APA, 2013):
* Patient awareness of a memory problem, preferably confirmed by another person who knows the patient
* Memory impairment detected with standard assessment tests
* Ability to perform normal daily activities
* For a broad definition of mild cognitive impairment, we also use guidelines to identify those with other mild cognitive impairment subtypes, including those with memory impairment and/or additional cognitive deficits (Winblad et al, 2004). The diagnosis will be corroborated by clinical judgment and include participants who score 1 standard deviation or more below the age-corrected norms bec…
What they're measuring
1
Clinical Dementia Rating Sum of Box Scores (CDR-SB)