Status:
COMPLETED
Cognitive Decline and Alzheimer's Disease in the Dallas Lifespan Brain Study
Lead Sponsor:
Neil M Rofsky, MD, MHA
Conditions:
Alzheimer Disease
Cognitive Decline
Eligibility:
All Genders
38-96 years
Phase:
PHASE2
Brief Summary
The investigators will conduct tau positron emission tomography (PET) scans on 125 adults using the radiopharmaceutical Flortaucipir F18 (\[18F\]AV-1451). This will allow the investigators to determin...
Detailed Description
Alzheimer's disease (AD) is a highly prevalent disorder of dementia in older adults. AD neuropathology is marked by the presence of amyloid plaques and tau neurofibrillary tangles. Autopsy studies, as...
Eligibility Criteria
Inclusion
- Participated in Wave 1 or 2 of the DLBS study.
- Subjects must indicate that they are not currently pregnant if they are women of child-bearing potential. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1) Has not undergone a hysterectomy or bilateral oophorectomy; or 2) Has not been naturally post-menopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Volumetric Brain MRI Image (T-1 Weighted MPRage) collected as part of DLBS Wave 1, 2, or 3 protocol.
- Completed at least 9 years of formal education, or the equivalent of freshman year of high school.
- Fluent English speakers.
- Tolerate laying 20 minutes on a flat table for the PET scan.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Mini-Mental State Examination (MMSE) score lower than 22; all DLBS participants at the time of initial Wave 1 enrollment between 2008 - 2014 had an MMSE score of 26 or above, indicating normal cognitive function. However, in the time interval between Wave 1 and Wave 3, it is possible that mental capacity may have deteriorated. The investigators will exclude all participants in Wave 3 testing who have an MMSE lower than 22.
- Taking some types of sedatives, benzodiazepines, or anti-psychotics.
- Currently undergoing chemotherapy or radiation for cancer.
- New history of substance abuse.
- Has a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence.
- Recreational drug use in past six months.
- Central nervous systems disease or brain injury that would preclude participation in the study.
- Psychiatric or neurological disorder that would preclude participation in this study.
- Has clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances which pose safety risk.
- Has a current clinically significant cardiovascular disease that poses a safety risk.
- Has a current clinically significant infectious disease or a medical comorbidity which poses a safety risk.
- Has either: 1) Screening electrocardiogram (ECG) with corrected QT Interval (QTc) \> 450 millisecond (msec) if male, or QTc \> 470 msec if female; or 2) A history of additional risk factors for Torsades de Pointes (TdP) (e.g., hypokalemia, family history of Long QT syndrome) or are taking drugs that are known to cause QT prolongation (a list of prohibited and discouraged medications is provided by the Sponsor); Patients with a prolonged QTc interval in the setting of intraventricular conduction block (examples right bundle branch block or left bundle branch block), may be enrolled with sponsor approval.
- Has received or will receive investigational medication within the 30 days of PET/CT scan.
- Has received or will receive a radiopharmaceutical for imaging or therapy within 24 hours of PET/CT scan.
- Is a participant who, in the opinion of the investigator(s), is otherwise unsuitable for a study of this type.
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04080544
Start Date
January 15 2019
End Date
June 30 2022
Last Update
September 28 2023
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390