Status:
COMPLETED
A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Frontotemporal Dementia
Pick Complex
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the safety and tolerability and the efficacy of galantamine treatment in subjects with Pick Complex/ Frontotemporal Dementia (PC/FTD). The safety and tolerabili...
Detailed Description
Pick Complex (PC) and Frontotemporal Dementia (FTD) are a group of neurodegenerative dementias, initially characterized by frontotemporal lobar atrophy, that have overlapping clinical presentations an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00416169
Start Date
May 1 2003
End Date
July 1 2004
Last Update
June 8 2011
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