Clinical Trial Details
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NCT01962779 : Sleep, Aging and Risk for Alzheimer's Disease
AgesMin: 50 Years Max: N/A
Inclusion Criteria:

- Male and female subjects with normal cognition and >50 years of age will be enrolled.
Younger subjects are not included as the risk for cognitive impairment is too low.
Moreover, by selecting this age-range we minimize the possibility of including
early-onset genetic forms of neurodegenerative diseases such as Alzheimer's disease
and Frontotemporal Dementia.

- Normal subjects will be within normal limits on neurological and psychiatric
examinations. All subjects enrolled will have both a Clinical Dementia Rating = 0 and
Global Deterioration Scale < 3.

- All subjects will have had a minimum of 12 years education.The education restriction
reduces performance variance on cognitive test measures and improves the sensitivity
for detecting pathology and disease progression using the robust norms available at
NYU School of Medicine.

- All subjects will have an informed family member or life partner interviewed to
confirm the reliability of the subject interview. All subjects will agree to the MRI
imaging, the lumbar puncture, apolipoprotein E (ApoE) genotyping and DNA banking

Exclusion Criteria:

- Diagnosis of any brain disease or MRI evidence of brain damage including significant
trauma, hydrocephalus, seizures, mental retardation or other serious neurological
disorder (e.g. Parkinson's disease or other movement disorders). Persons with silent
cortical infarcts are excluded. Subcortical infarcts and white matter lesions are not

- History of brain tumor.

- Any radiation or chemotherapy anywhere in the body in the past 3-years.

- Significant history of alcoholism or drug abuse.

- History of psychiatric illness (e.g., schizophrenia, mania, PTSD, or life long
history of major depression).

- Hamilton Depression Scale >16 only with history of life long depressive episodes.
Otherwise not excluded.

- Evidence of clinically relevant and uncontrolled cardiac, pulmonary, or hypothyroid
or hematological conditions. Insulin dependent diabetes and/or history or treated
hypertension are not an exclusion. Normal subjects with current levels of HbA1c >5.9%
or diabetics >7.0% (American Diabetes Association, 2010) and/or current blood
pressure levels >140/90 mm Hg (JNC on Prevention, Detection, Evaluation and Treatment
of High Blood Pressure, 2003) will be advised to seek referral.

- Physical impairment of such severity as to adversely affect the validity of
psychological testing.

- Hostility or refusal to cooperate.

- Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard
for MRI imaging.

- History of a first-degree family member with early onset (before age 65) dementia.

- Medications adversely affecting cognition will result in exclusion. The excluded
medications include:

- Antidepressants with anti-cholinergic properties.

- Regular use of narcotic analgesics (>2 doses per week).

- Use of neuroleptics with anti-cholinergic properties.

- Other medications with central nervous system anticholinergic activity.

- Use of Anti-Parkinsonian medications.

- At the baseline individuals taking physician ordered or off-label memory or other
cognitive enhancing medications (e.g. cholinesterase inhibitors or memantine) are
excluded. At the follow-up these medications are allowed. Also excluded at baseline
are individuals taking physician ordered, but off-label memory enhancements.
Individuals taking over the counter memory enhancing or protecting medications (e.g.
ginkgo biloba, vitamins) are not excluded.

- Patients with significant physical changes (e.g. amputations or loss of sensory
input) as these may affect the MRI blood flow measures.
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