View Clinical Trial (Medical Research Study)
Amyloid Plaque and Tangle Imaging in Alzheimer's Disease and Down Syndrome
| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90024 |
| Conditions: |
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Down Syndrome - Alzheimer's Disease |
| Purpose: |
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The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid,
to be used with positron emission tomography (PET) for early detection and treatment
monitoring of Alzheimer disease (AD). The study hypothesis is that PET imaging of small
molecule probes, in the form of novel fluorescent dyes with radioactive labels, will
demonstrate cerebral patterns in patients with AD that are distinct from those of
age-matched persons who are cognitively intact.
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| Study Summary: |
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This is a naturalistic study in which clinical evaluations and brain scans will be performed
on 20 people with Down syndrome (DS) as well as 20 healthy controls across a range of ages.
Participants will receive comprehensive clinical and neuropsychological assessments. PET and
MRI scans will be performed at baseline and after two years of follow up. All participants
will have blood drawn for APOE genotyping during their baseline evaluations. The
intellectual range of participants with DS will be restricted to IQ scores of 45 to 60
(moderate range) to reduce variability, particularly due to extreme low levels of
intellectual ability.
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| Criteria: |
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Inclusion Criteria:
- Age 21 years or older
- No significant cerebrovascular disease - modified Ischemic Score of < 4
- Adequate visual and auditory acuity to allow neuropsychological testing
- Screening laboratory tests and ECG without significant abnormalities that might
interfere with the study
Additional Inclusion Criteria for Controls
- MMSE score between 24 and 30 (unless < 8 years of educational achievement)
- The following medications are allowed if stable for > 1 month: antidepressants
(without anticholinergic effects) if not currently depressed and no history of major
depression for 2 years; estrogen replacement therapy; thyroid replacement therapy as
long as individual is euthyroid; antihypertensives that do not influence cognitive
function
Additional Inclusion Criteria for Individuals with Down syndrome
- Family member or caregiver available; caregiver relationship 2 years or longer
- Karyotype DX of trisomy or translocation DS Mosaic form of Down syndrome
- English-speaking
Exclusion Criteria:
- Evidence of neurological or other physical illness that could produce cognitive
deterioration; volunteers with a history of TIAs, carotid bruits, or lacunes on MRI
scan will be excluded
- Parkinson's Disease
- History of myocardial infarction within the previous year or unstable cardiac disease
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100), history of
significant liver disease, clinically significant pulmonary disease, diabetes, or
cancer
- Major psychiatric disorders, such as bipolar disorder or schizophrenia
- Medicines that could influence psychometric test results
- Use of any of the following drugs: centrally active beta-blockers, narcotics,
clonidine, anti-Parkinsonian medications, benzodiazepines, systemic corticosteroids,
medications with significant cholinergic or anticholinergic effects,
anti-convulsants, or warfarin
- Current diagnosis or history of alcoholism or drug dependence
- Evidence of untreated depression or untreated anxiety
- Use of any investigational drugs within the previous month or longer, depending on
drug half-life
- Contraindication for MRI scan (e.g., metal in body, claustrophobia)
- Diagnosis of possible or probable AD or any other dementia (e.g., vascular, Lewy
body, frontotemporal) or MCI
Additional Exclusion Criteria for Individuals with Down syndrome
- Mosaic form of Down syndrome
- History of clinically significant neurological disorder or disease and Psychiatric
diagnosis or treatment within 3 months prior to screening
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| NCT ID: |
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NCT00965835 |
| Primary Contact: |
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Principal Investigator
Linda Nelson, PhD
Semel Institute, UCLA
Andrea Kaplan
Phone: 310-825-0545
Email: akaplan@mednet.ucla.edu
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| Backup Contact: |
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Email: ddorsey@mednet.ucla.edu
Deborah Dorsey, RN
Phone: 310-825-0545
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| Location Contact: |
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Los Angeles, California 90024
United States
Andrea Kaplan, BA
Phone: 310-825-0545
Email: akaplan@mednet.ucla.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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