Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT00965835
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00965835
Study Brief:
Protocol Section:
NCT00965835