CMK-0301 is a multi-site, randomized clinical trial to evaluate the safety and efficacy of \[F-18\]Flornaptitril-PET (F-18 FNT-PET) for the prediction of clinical progression of Mild Cognitive Impairment (MCI) with either Suspected Chronic Traumatic Encephalopathy (CTE) or Alzheimer's Disease (AD). The primary objectives of the study are to: (1) To determine the accuracy of F-18 FNT-PET in prediction of clinical decline and (2) To assess the safety and tolerability of F-18 FNT. The secondary objectives include: (1) To demonstrate the feasibility of F-18 FNT-PET in differentiation of participants with suspected chronic traumatic encephalopathy (CTE) from those with suspected Alzheimer's disease (AD) by trained image readers, (2) To evaluate disease progression in participants with suspected CTE or AD and (3) To evaluate the correlation between F-18 FNT-PET regional and summary visual reads scan and other assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
230
All participants will receive a single dose of F-18 FNT during an imaging visit.
Endeavor Health Systems
Evanston, Illinois, United States
RECRUITINGAccuracy of F-18 FNT-PET in prediction of clinical decline
The correlation between predictive development of neurodegeneration as made from F-18 FNT-PET and score change from baseline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at the 2-year Follow-up Visit
Time frame: 2 years
Assessment of the safety of F-18 FNT using adverse events and serious adverse events.
Adverse events and serious adverse events will be monitored in patients following F-18 FNT administration.
Time frame: 2 years
Assessment of the safety of F-18 FNT using vital signs.
A patients body temperature, respiratory rate, sitting radial pulse rate, and sitting systolic and diastolic blood pressures will be monitored in patients following F-18 FNT administration.
Time frame: 2 years
Assessment of the safety of F-18 FNT using clinical laboratory assessments.
A patients complete blood count with differential, free T4 Index, Vitamin B12 serum, chemistry panel (glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin and total protein, ALP, ALT, AST, bilirubin, BUN, creatinine), benzodiazepines, uric acid, thyroid-stimulating hormone, and cholesterol will be monitored in patients following F-18 FNT administration.
Time frame: 2 years
Assessment of the safety of F-18 FNT using electrocardiograms
12-Lead electrocardiograms (ECGs) will be performed for all participants at Screening and in-person Follow-up Visit(s). Triplicate 12-lead ECG measurements will be obtained approximately 2 minutes apart. A repeat 12-lead ECG recording may be obtained to confirm ECG findings at the discretion of the Investigator. A full assessment of the ECG will be performed including P Wave, QRS Complex, and QT Interval.
Time frame: 2 years
Assessment of the safety of F-18 FNT using the Suicide Behavior Questionnaire-Revised
The Suicide Behavior Questionnaire-Revised will be given and assessed in patients following F-18 FNT administration.
Time frame: 2 years
Feasibility of F-18 FNT-PET to differentiate suspected CTE from suspected AD.
The binding patterns of F-18 FNT-PET will be assed in each patient to differentiate those patients with suspected chronic traumatic encephalopathy (CTE) from those with suspected Alzheimer's disease (AD) by trained image readers using pattern determination (for presence versus no presence of CTE or AD type pattern).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the CDR-SB at the 2-year follow-up visit.
The change from baseline in scores on the Clinical Dementia Rating Scale Sum of Box Scores (CDR-SB) at the 2-year follow-up visit will be used to assess the disease progression in participants with suspected CTE or AD.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the 36-Item Short Form Survey (SF-36).
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of 36-Item Short Form Survey (SF-36).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the STOP-BANG Questionnaire for Sleep Apnea.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the STOP-BANG Questionnaire for Sleep Apnea.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Pittsburgh Sleep Quality Index.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Pittsburgh Sleep Quality Index.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Mini Mental State Examination (the 2nd edition).
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Mini Mental State Examination (the 2nd edition).
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Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Modified Balance Error Scoring System.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Modified Balance Error Scoring System.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Modified Balance Error Scoring System..
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Modified Balance Error Scoring System.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the quality of life in neurological disorders (Neuro-QOL).
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the quality of life in neurological disorders (Neuro-QOL).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Hamilton Rating Scale for Depression (17 items).
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Hamilton Rating Scale for Depression (17 items).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Hamilton Anxiety Scale.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Hamilton Anxiety Scale
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Pfeffer Functional Activities Questionnaire.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Pfeffer Functional Activities Questionnaire
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Geriatric Depression Scale.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Geriatric Depression Scale.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Cognitive Function Instrument.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Cognitive Function Instrument.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Modified Overt Aggression Scale.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Modified Overt Aggression Scale.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Wechsler Memory Scale.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Wechsler Memory Scale.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Logical Memory Immediate/Delayed Recall score.
Wechsler Memory To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the 4th edition (WMS-IV) Logical Memory Immediate/Delayed Recall score.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Visual Memory Index score.
Wechsler Memory To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Visual Memory Index score.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Multilingual Naming Test- 32 item version.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Multilingual Naming Test- 32 item version (20 minutes).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Wechsler Adult Intelligence Scale.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Wechsler Adult Intelligence Scale.
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Digit Span test.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the 4th edition (WAIS-IV) Digit Span (7 minutes).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Animal Naming Test.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Animal Naming Test (3 minutes).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using Trail Making Test.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Trail Making Test: Trails A and Trails B (6 minutes).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Test of Memory Malingering.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Test of Memory Malingering (20 minutes).
Time frame: 2 years
Evaluation of disease progression in participants with suspected CTE or AD using the Peabody Picture Vocabulary Test.
To evaluate disease progression in participants with suspected CTE or AD using change from baseline of the Peabody Picture Vocabulary Test (15 minutes).
Time frame: 2 years
Evaluation of the correlation between F-18 FNT-PET and baseline clinical and demographic data.
To evaluate the correlation between F-18 FNT-PET images and a patient's baseline clinical and demographic data. The evaluation of the correlation between F-18 FNT-PET and baseline clinical and demographic data does not explicitly include the baseline clinical and demographic data.
Time frame: 2 years
Evaluation of the correlation between F-18 FNT-PET and conversion to dementia
To evaluate the correlation between F-18 FNT-PET images and a patient's conversion to dementia. The evaluation of the correlation between F-18 FNT-PET and conversion to dementia does not explicitly include the conversion to dementia data.
Time frame: 2 years
Evaluation of the correlation between F-18 FNT-PET and decline in executive function.
To evaluate the correlation between F-18 FNT-PET images and a patient's decline in executive functioning domain score of a trial specific assessment battery (neuropsychiatric and neuropsychological examinations). The evaluation of the correlation between F-18 FNT-PET and decline in executive function does not explicitly include the decline in executive function data.
Time frame: 2 years