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A Pilot Study to Explore the Safety and Tolerability of Galantamine HBr in the Treatment of Pick Complex/Frontotemporal Dementia
This study has been completed.
First Received: December 22, 2006   Last Updated: October 19, 2007   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00416169
  Purpose

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 tolerability of galantamine therapy will be assessed over the entire treatment period (26 weeks). The 8 week withdrawal period will be used to confirm the safety of galantamine withdrawal in this subject group and it impact on any symptom improvement achieved during the first 18 weeks of galantamine treatment ( symptom improvement would be expected to stabilize or decline on withdrawal of an effective therapy). The primary efficacy objective is to explore the effect of galantamine on behavior as measured by the Frontal Behavioral Inventory during the randomized withdrawal period. In addition, for subjects with primary progressive aphasia (limited ability for languages), the effects of galantamine on language will be explored using the Aphasia Quotient of the Western Aphasia Battery, and for all subjects the Clinical Global Impressions will be used to explore global change.


Condition Intervention Phase
Pick Complex
Frontotemporal Dementia
Drug: galantamine hydrobromide
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open Pilot Study to Evaluate the Safety and Efficacy of Galantamine in the Treatment of Pick's Disease/Frontotemporal Dementia /Pick Complex

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Estimated Enrollment: 40
Study Start Date: April 2003
Estimated Study Completion Date: July 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416169

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR003106
Study First Received: December 22, 2006
Last Updated: October 19, 2007
ClinicalTrials.gov Identifier: NCT00416169     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
galantamine hydrobromide
Pick Complex
Frontotemporal Dementia

Additional relevant MeSH terms:
Parasympathomimetics
Pick Disease of the Brain
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Brain Diseases
Cholinergic Agents
Aphasia, Primary Progressive
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Dementia
Neurobehavioral Manifestations
Nootropic Agents
Speech Disorders
Galantamine
Aphasia
Nervous System Diseases
Language Disorders
Central Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Autonomic Agents
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents
Communication Disorders

ClinicalTrials.gov processed this record on November 27, 2009