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

NCT00035204 | Completed Phase 4

• 1 other identifier: CR002002
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alzheimer Disease

Keywords

Donepezil; Alzheimer's; Dementia; Cognitive impairment; Aricept; Alzheimer's disease; Razadyne; Galantamine

Outcome Measures

Primary Outcomes (1)

• To measure the differences between galantamine and donepazil for sleep and attention, explore methods of measuring sleep in patients with Alzheimer's Disease (AD)and their caregivers and attention in AD patients; GI tolerance

Secondary Outcomes (1)

• To assess the tolerability, overall effect, quality of life and safety of galantamine compared with donepezil

Interventions

galantamine 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (1)

• McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

  PMID: 33189083 DERIVED

Related Links

• A double-blind, randomized pilot study to evaluate the effects of galantamine and donepezil on sleep and attention and gastrointestinal (GI) tolerance in patients with mild to moderate Alzheimer's disease (AD).

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Interventions

Galantamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Completion: May 1, 2003
• Last Updated: June 8, 2011

Record last verified: 2010-04