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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT00416169
Eligibility Criteria:
Inclusion Criteria:
* Outpatients with a clinical diagnosis of Frontotemporal Dementia or Pick Complex (PC/FTD) documented for at least 1 year with either primary progressive aphasia or frontotemporal dementia
* recent MRI or CT confirming frontotemporal lobar atrophy consistent with Frontotemporal Dementia or Pick Complex PC/FTD
* opportunity to perform certain activities of daily living as described in the Alzheimer's Disease Cooperative Study -- Activities of Daily Living Inventory
* living with or having regular visits (least 4 days/week) from a responsible caregiver
* Mini Mental State Examination score \> 5 and the ability to complete baseline neuropsychometric testing
* able to see, hear, and communicate sufficiently, and willing to complete serial neuropsychometric tests
* female subjects of childbearing age must be surgically sterile or practicing an effective method of birth control before entry and throughout the study.
Exclusion Criteria:
* No neurodegenerative disorders and other causes of dementia or cognitive impairment from acute cerebral injuries, cerebrovascular disease or hypoxic cerebral damage, vitamin deficiency states, infection cerebral neoplasia
* no primary memory disturbance or an amnestic syndrome more compatible with Alzheimer's disease or other primary degenerative dementia
* no uncontrolled epilepsy or clinically significant psychiatric disease, cardiovascular disease, hepatic, renal, pulmonary, metabolic, or endocrine disturbances, active peptic ulcer and urinary outflow obstruction
* no use of any agent used for the treatment of dementia or other cognitive impairment
* no history of severe drug allergy or hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents, or bromide
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT00416169
Study Brief:
Protocol Section:
NCT00416169