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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT00539305
Eligibility Criteria:
Inclusion Criteria:
* Male 60-90 years of age
* Diagnosis of mild cognitive impairment (MCI)
* Low testosterone level
* Primary language is English
* Availability of an informant who knows the participant well enough to answer questions
* Stable medications for the previous 3 months
* Normal complete blood count (CBC), and no clinically significant blood chemistry
* American Urological Association (AUA) symptom score less than or equal to 19
* Body Mass Index (BMI) less than 33 and stable weight in the previous year
Exclusion Criteria:
* Prior history of prostate cancer or prostate specific antigen level greater than 4.0ng/ml
* Peripheral or vascular disease
* Significant history of alcohol abuse, current alcohol abuse (more than 2 drinks per day), or other substance abuse
* History of severe head injury (with loss of consciousness greater than 30 minutes)
* Significant neurological illness, such as Parkinson's disease, seizure disorder, multiple sclerosis, major stoke
* Smokes cigarettes
* Major psychiatric illness, such as schizophrenia or bipolar disorder
Prohibited Medications:
* Anti-convulsants
* Anti-psychotics
* Sedating antihistamines
* Sedative/hypnotics
* Benzodiazepines
* Hormone or testosterone regimens
* Gonadotropin-releasing hormone (GNRH) antagonists
* Flutamide
* Anti-depressants and/or anti-cholinesterase inhibitors, but acceptable if on stable dose for 3 months or more
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT00539305
Study Brief:
Protocol Section:
NCT00539305