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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT00254033
Eligibility Criteria:
Inclusion Criteria:
* age \> 55 years
* meet DSM-IV criteria for primary degenerative dementia
* meet NINCDS-ARDA criteria for probable Alzheimer's Disease of at least one year's duration
* mild to moderate cognitive impairment (Global Deterioration Scale GDS \<6, Mini-Mental State Examination \>10
* on a stable dose of a cholinesterase inhibitor for at least 3 months
* apathetic group only: Neuropsychiatric Inventory (NPI) Apathy subscale score \>=2
Exclusion Criteria:
* abnormal biochemical screening: blood cell count, vitamin B12, thyroid function tests, and syphilis screening tests
* significant medical illness or other medical/neurological conditions which diminish cognitive function
* evidence of seizure disorder
* an Hachinski ischemic score \>3 indicating vascular dementia
* a brain computed tomographic (CT) scan revealing focal lesions, or inconsistent with AD
* electrocardiographic, laboratory or physical evidence of significant cardiovascular disease
* presence of premorbid or current psychiatric diagnosis including: major depression, schizophrenia, psychotic symptoms of a severity likely to provoke violent or dangerous behaviour (i.e., command hallucinations to harm people or persecutory delusions that provoke violent reactions)
* current or past psychoactive substance abuse or dependence (including alcohol, excluding nicotine)
* contraindications to receiving dextroamphetamine or methylphenidate
* have had administration of a depot neuroleptic injection within one treatment cycle of the first visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT00254033
Study Brief:
Protocol Section:
NCT00254033