| Eligibility |
Inclusion Criteria:
- Mild AD Subjects:
- National Institute on Aging (NIA)-Alzheimer's Association core clinical criteria for
probable AD
- Age between 55 and 90 (inclusive)
- Score on the Montreal Cognitive Assessment (MOCA) greater than or equal to 17
- Presence of a responsible caregiver who will accompany AD subjects to all procedures.
- Biomarker evidence of Alzheimer's disease via an amyloid PET scan or cerebrospinal
fluid (CSF) amyloid Beta measurement.
- The patient should have the capacity to consent.
- Clinical Dementia Rating (CDR) global score greater than 0.
- Cognitively normal elderly Subjects:
- Absence of National Institute on Aging-Alzheimer's Association core clinical criteria
for probable AD
- Objective memory scores within the normal range for age (do not meet MCI Subjects
criterion 2)
- Age between 55 and 90 (inclusive)
- Clinical Dementia Rating (CDR) global score of 0.0
Exclusion Criteria:
- Any significant neurologic disease (other than probable AD in the AD Subjects group),
such as stroke, Parkinson's disease, brain tumor, seizure disorder, multiple
sclerosis, or history of significant head trauma followed by persistent neurologic
deficits.
- Any significant systemic disease including hepatic failure, heart failure, renal
failure, chronic obstructive pulmonary disease (COPD), active infection and autoimmune
disease.
- Screening/baseline MRI scan with evidence of infection, infarction, or other focal
lesions. Subjects with multiple lacunes or lacunes in a critical memory structure are
excluded.
- Any significant systemic illness or unstable medical condition, including uncontrolled
or insulin- dependent diabetes mellitus, uncorrected hypothyroidism or
hyperthyroidism, or systemic cancer.
- Current or regular use of over-the-counter medication that may affect the immune
system (e.g., ibuprofen), including corticosteroids or immunosuppressant drugs; no use
in 3 weeks prior to the PET scan
- Investigational agents are prohibited 4 weeks prior to entry and for the duration of
the study.
- Previous treatment with an investigational small molecule with anti-amyloid properties
or passive immunization against amyloid within 1 year of study entry.
- Previous treatment with an active immunization against amyloid.
- History of schizophrenia or other major psychiatric disorder (DSM IV criteria).
- History of alcohol or substance abuse or dependence (DSM IV criteria) within the past
2 years.
- Clinically significant abnormalities on screening laboratory tests (B12, Thyroid
function tests, hematology, chemistry, urinalysis, ECG).
- Pregnancy, as determined by screening pregnancy tests for pre-menopausal females
- Impairment of visual or auditory acuity sufficient to interfere with study procedures.
- Education level < 6 years.
- Evidence of current depression as defined by a score of = 5 on the Geriatric
Depression Scale.
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal
fragments or foreign objects in the eyes, skin or body. The presence of
claustrophobia, precluding MRI.
- Current or recent participation in any procedures involving radioactive agents such
that the total radiation dose exposure to the subject in any given year would exceed
the limits of annual and total dose commitment set forth in the US Code of Federal
Regulations (CFR) Title 21 Section 361.1.
- Vaccination in the last month.
- Drink more than 5 alcoholic drinks per week or any heavy drinking days in the last 30
days.
- BMI > 35 or < 19
- Women who are pregnant or nursing, or fail to use one of the following methods of
birth control unless she or partner is surgically sterile or she is postmenopausal
(hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive
sponge, double barrier [diaphragm or condom plus spermicide], or Intrauterine Device
(IUD)
- Individuals who are classified as "low binders" for the rs6971 polymorphism (<10% of
the population)
- Patients on antiplatelet and anticoagulant medications will be excluded.
- Any patient without the capacity to consent will be excluded.
- Unstable hypertension. If blood pressure is greater than 160/100, the investigators
will contact the subject's primary care physician to manage their blood pressure. If
their blood pressure is not reduced to be consistently below 160/100 by the scanning
day the subject will be excluded from the protocol.
- Patients with contraindications for lumbar puncture procedure can be still involved
and will be excluded from the optional portion of the study with the lumbar puncture.
These include existing intracranial space-occupying lesion with mass effect, posterior
fossa mass, risk of cerebral herniation by increased CSF pressure or Arnold chiari
malformation, as well as anticoagulant medication, coagulopathies and uncorrected
bleeding diathesis, congenital spine abnormalities, and local skin infection at the
puncture site.
|
