Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease

NCT00082602 | Completed Phase 3

• 1 other identifier: CR004699
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of an extended release formulation of the drug galantamine using a rapid dose escalation regimen.

Conditions

Alzheimer's Disease

Keywords

galantamine; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• The primary end point occurs at Week 8. The primary outcome measures will be tolerability and safety through rates of adverse events.

Secondary Outcomes (1)

• The secondary end point occurs at Week 12. The secondary outcome measure will be the Mini Mental State Examination score.

Interventions

galantamine ER DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients diagnosed with Alzheimer's Disease
• Age \>= 60 years
• Presence of mild to moderate dementia as evidenced by Mini Mental State Examination (MMSE) score of 10-24 inclusive at screening
• History of cognitive decline that had been gradual in onset and progressive over a period of at least six months

You may not qualify if:

• Neurodegenerative disorders
• One of the following conditions possibly resulting in cognitive impairment: Acute cerebral trauma or injuries secondary to chronic trauma (such as boxing), hypoxic cerebral damage, whether or not due to acute or chronic cerebral hypoperfusion
• Vitamin deficiency states, such as folate, vitamin B12 or other B complex deficiencies
• Neurosyphilis or other infections resulting in cerebral abscesses, meningitis, or encephalitides such as AIDS
• Primary or metastatic cerebral neoplasia
• Significant endocrine or metabolic disease e.g., untreated or uncontrolled thyroid, parathyroid or pituitary disease, Cushing's syndrome, severe renal failure or uncontrolled diabetes mellitus
• Mental retardation or oligophrenia
• Multi-infarct dementia or clinically active cerebrovascular disease as evidenced by: a history of a significant cerebrovascular event yielding a physical or neurologic deficit likely to confound the assessment of the subject's intellectual function, multiple focal signs on neurological examination indicative of multiple ischemic attacks, significant findings on an available CT or MRI scan taken within the last 12 months
• Subjects with the following co-existing medical conditions: Any history of epilepsy or convulsions except for febrile convulsions during childhood
• Current clinically significant psychiatric disease, in particular current major depression, schizophrenia, bipolar disorder, moderate to severe or uncontrolled behavioral disturbances
• Peptic ulcer disease: if the ulcer is considered to be still active, or if treatment is not successful (symptoms present)
• Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
• Clinically significant urinary outflow obstruction
• Current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 12-Week trial. The following would usually be considered clinically significant cardiovascular diseases: cardiac surgery or myocardial infarction within the past 6 months, angina or coronary artery disease that required a change in anti-angina medication within the last 3 months, decompensated congestive heart failure, cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status, atrial fibrillation, bradycardia \< 50/min., atrio-ventricular block \> first degree
• Severe mitral or aortic valvular disease

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Related Links

• Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2004
• First Posted: May 17, 2004
• Study Start: May 1, 2004
• Study Completion: April 1, 2005
• Last Updated: May 20, 2011

Record last verified: 2009-04