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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416169
Recruitment Status : Completed
First Posted : December 27, 2006
Last Update Posted : June 8, 2011
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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 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 or disease Intervention/treatment Phase
Frontotemporal Dementia Pick Complex Drug: galantamine hydrobromide Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : May 2003
Actual Study Completion Date : July 2004

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416169

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

Additional Information:
Layout table for additonal information Identifier: NCT00416169     History of Changes
Other Study ID Numbers: CR003106
First Posted: December 27, 2006    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: January 2011
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Frontotemporal Dementia
Pick Complex
galantamine hydrobromide
Additional relevant MeSH terms:
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Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Lobar Degeneration
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents