CSF Clearance in Sporadic Alzheimer’s Disease

Clinical Trial Details

We have developed and validated a non-invasive method to estimate the clearance of cerebrospinal fluid (CSF) from the brain. This study tests the hypothesis that reduced CSF clearance is predictive of a) future amyloid lesions, b) brain atrophy, and c) cognitive decline in healthy elderly adults or those with Mild Cognitive Impairment (MCI).

Measuring brain CSF clearance with novel, experimental imaging techniques may advance the understanding of Alzheimer’s disease (AD) progression at its earliest stages.

All subjects will be enrolled at Weill Cornell Medicine. Study participation consists of 3-5 visits, lasts approximately two years and involves: 1) medical assessment with neurologist, 2) surveys assessing subjective health and well-being, 3) cognitive testing, 4) brain MRI, 5) amyloid PET-CT (FDA approved), 6) tau PET-CT, routine blood & urine analyses, donation of blood for research purposes. The visits occur using telehealth technology, and 3-5 in-person at the Weill Cornell Medicine Clinical and Translational Science Center (CTSC) and the Citigroup Biomedical Imaging Center (CBIC).

Key Eligibility:

Inclusion Criteria:

Male and female subjects 55-100 years old.
All subjects will speak English as their first language or demonstrate proficiency in English.
Participants may or may not have a diagnosis of MCI or early AD.

Exclusion Criteria:

Existing confirmation of genetic mutations that cause early-onset AD. Such mutations will not be screened during this study but may be disclosed by the prospective subject.
History of a first-degree family member with early onset (age < 60 years) dementia.
Presence of brain tumor and other neoplastic disorders outside the brain where disease itself or its treatment (radiation, chemotherapy) is likely to affect brain structure or function; history or MRI evidence of stroke.
Implanted medical devices that are incompatible with MRI imaging and radiation exposures exceeding Radiation Worker limits. Medical records, CT or x-ray may be used to establish suitability for MRI.
Lifelong major depression, Individuals developing depression at the follow-up visit will not be excluded as depression is a risk-factor for MCI.
All physical (e.g. amputations) or behavioral conditions (e.g. substance abuse) that might alter brain and cognitive function assessments. Reliable examination and interview procedures have been in routine use for many years.
Pregnancy is exclusionary. Urine pregnancy tests may be conducted with pre-menopausal women.
Medications affecting cognition, all dosing is reviewed by study physician.
Evidence of clinically relevant and uncontrolled (as deemed by the study physician) hypertension, cardiac, pulmonary, vascular, metabolic or hematological conditions.