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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01841905
Eligibility Criteria:
Inclusion Criteria:
* Individuals between the ages of 55 and 80 years old (inclusive).
* MMSE total score \> 27
* Two risk factors for AD:
* Subjective memory complaints.
* A positive (suspected) first-degree family history for the disease.
* Permitted medications stable for at least 1 month prior to screening.
* Subjects may take stable doses of antidepressants lacking significant anticholinergic side effects (do not have a history of major depression within the past year).
* Estrogen replacement therapy.
* Adequate visual and auditory acuity to allow neuropsychological testing.
* Good general health or without any clinically significant abnormalities .
* Vitamin supplements (including Vitamin E) will be acceptable.
* Subjects must be willing and able to provide written informed consent.
Exclusion Criteria:
* History of major traumatic brain injury, other known neurologic disease or insult
* Mini Mental State Examination (MMSE)total score \< 27
* Regular (daily) use of narcotics or antipsychotic medications
* Poorly-controlled major depression or another Axis I psychiatric disorder as described in DSM-IV within the past year.
* Psychotic features, agitation or behavioral problems, within the last 3 months.
* History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
* History of schizophrenia (DSM IV criteria).
* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol including:
* History of systemic cancer within the past 5 years (non-metastatic skin cancers are acceptable).
* History of myocardial infarction in the past year or unstable or severe cardiovascular disease including angina or Congestive Heart Failure (CHF) with symptoms at rest.
* Clinically significant obstructive pulmonary disease or asthma.
* Clinically significant and unstable gastrointestinal disorder within two years.
* Insulin-requiring diabetes or uncontrolled diabetes mellitus.
* Uncontrolled hypertension (systolic BP \> 170 or diastolic BP \> 100).
* History of clinically significant liver disease, coagulopathy, or vitamin K deficiency within the past 2 years.
* History of symptoms of narrow-angle glaucoma.
* Clinically significant obstructive uropathy
* Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening.
* Use of anti-Parkinsonian medications (e.g., Sinemet, amantadine, bromocriptine, pergolide and selegiline) within 2 months prior to screening.
* Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening.
* Use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screen.
* Use of short-acting anxiolytics or sedative-hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of the baseline and follow-up visits.
* Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable)
* Use of systemic corticosteroids within 3 months prior to screening.
* Medications with significant cholinergic or anticholinergic side effects within 4 weeks prior to screening.
* Use of anti-convulsants within 2 months prior to screening.
* Use of warfarin (Coumadin) within 4 weeks prior to screening.
* Any prior use of any FDA approved medications for the treatment of Alzheimer's disease (e.g., tacrine, donepezil, or other newly approved medications).
* Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening.
* Subjects who, in the investigator's opinion, will not comply with study procedures.
* Known hypersensitivity to F-18, tropicamide, and/or scopolamine or agents of this class of drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT01841905
Study Brief:
Protocol Section:
NCT01841905