A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00416169
• Date of registration: 22/12/2006
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia
• Scientific title: An Open Pilot Study to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Pick's Disease/Frontotemporal Dementia /Pick Complex
• Date of first enrolment: May 2003
• Target sample size: 41
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00416169
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia

Pick Complex

Intervention(s)

Drug: galantamine hydrobromide

Primary Outcome(s)

The safety is incidence of gastrointestinal events; efficacy are FBI, AQ and CGI. Changes will be calculated from baseline to Week 18 and Week 26. Comparisons between the placebo and galantamine groups will use the changes from Weeks 18 to 26.

Secondary Outcome(s)

Secondary efficacy parameters are: MMSE, MDRS, FAB, NPI, ADCS-ADL Scale, subscales of the WAB and FBI and neurologic exams; safety are AE, ECGs, physical exam, vital signs, and lab tests.

Secondary ID(s)

CR003106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors