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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Galantamine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Uncontrolled high blood pressure (systolic blood pressure > 170 mmHg or diastolic blood pressure > 110 mmHg) or sustained hypotension

• Any agent being used for the treatment of dementia (approved, experimental or over the counter agents

• Subjects who have previously received Cognexâ, Ariceptâ, metrifonate, Exelonâ, Reminyl, or Namendaâ for treatment of Alzheimer's disease, no matter if approved or experimental can be included in this trial provided that during the 30 days prior to baseline they were not taking these agents

• O History of drug or alcohol abuse within the last year or prior prolonged history of the same

• Female subjects of childbearing potential

• Subjects who in the opinion of the investigator are otherwise unsuitable for a trial of this type

• History of severe drug allergy or hypersensitivity, including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or identical agents, or bromide

• Subjects who have previously been enrolled in other galantamine trials

• Subjects who have received an investigational medication within the last 30 days

• Conditions that could interfere with the absorption of the compound or with the evaluation of the disease

• Employees of the investigator