A Study of the Effects on Sleep, Attention, and Gastrointestinal Tolerance of Galantamine and Donepezil in Patients With Alzheimer's Disease

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the relative effects of galantamine compared to donepezil (both cholinesteraste inhibitors), on sleep, attention, and gastrointestinal tolerance in patients with Alzheimer's disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male or post-menopausal female out-patients diagnosed with Alzheimer's disease

• Patients should have mild to moderate dementia as evidenced by a Mini-Mental State Examination score of 10-24 inclusive at screening

• The patient must show a history of cognitive decline that has been gradual in onset and progressive over a period of at least six months

• There must be evidence of sustained memory deterioration in an otherwise alert patient, plus additional impairment in at least one of the following five areas: orientation, judgement and problem solving, functioning in community affairs, functioning in home and hobbies, or functioning in personal care

• The caregiver resides with the patient and is able to speak with the investigative team about the patient's activities, medication use and adverse events. In addition, the caregiver will participate in assessment interviews and complete questionnaires for themselves and the patients. The caregiver will monitor their own sleep, the patient's sleep, and complete questionnaires regarding sleep patterns and care giving activities

Exclusion Criteria:

• Neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease

• One of the following conditions possibly resulting in cognitive impairment: acute cerebral trauma or injuries secondary to chronic trauma, hypoxic cerebral damage, e.g., post resuscitation (cardiac arrest, post anesthesia, secondary to severe self-poisoning episode, or secondary to severe hypovolemia)

• Patients with the following medical conditions: any history of epilepsy or convulsions except for febrile convulsions during childhood, clinically significant: endocrine disease, metabolic disease, psychiatric disease, cardiovascular disease, peptic ulcer disease, hepatic disease, renal disease, pulmonary disturbances or urinary outflow obstruction

• Use of any agent for the treatment of dementia (approved, experimental or over the counter agents) including patients who have previously received tacrin, donepazil, metrifonate, rivastigmine tartrate, galantamine, or memantine for treatment of Alzheimer's disease