Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035204
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2002-05-02
Brief Title:
A Study of the Effects on Sleep Attention and Gastrointestinal Tolerance of Galantamine and Donepezil in Patients With Alzheimers Disease
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
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 Alzheimers Disease AD
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers disease
Detailed Description:
This is designed as a pilot preliminary study to evaluate the differences in effects on attention sleep problems and gastrointestinal tolerance associated with Alzheimers Disease with two different drugs at two different doses Patients must have mild to moderate Alzheimers Disease based on the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimers Disease and Related Disorders Association NINCDS-ADRDA criteria and a Mini-Mental State Examination MMSE score of 10 to 24 The trial will consist of a 2-week run-in phase an 8-week assessment phase and an extension phase of variable length 6 weeks to 54 weeks During the study patients will be randomized assigned by chance to receive either galantamine or donepezil Galantamine will be given by mouth 4mg twice daily for Weeks 1-4 and then 8mg twice daily for Weeks 5-8 and beyond for participants in the extension The patients on donezepil will receive 5mg by mouth at bedtime for Weeks 1-4 and then 10mg at bedtime for Weeks 5-8 and beyond Placebo tablets will be given so that each patient takes two capsules per dose in order to conceal the identity of the drugs Neither the patient nor the physician will know which drug the patient is receiving Drug effectiveness will be measured by change in overall functioning of the patient shown by the Clinicians Interview-Based Impression of Change Plus Family Input CIBIC-Plus Other tests to evaluate whether the drug is effective will include the change in results of attention tests Simple Reaction Time SRT Choice Reaction Time CRT Verbal Series Attention Test VSAT and Stroop Test and in sleep pattern tests tests that measure movements during sleep Actiwatch and patterns of sleep such as the caregiver-completed Pittsburgh Sleep Quality Index PSQI and the Circadian Sleep Inventory for Normal and Pathological States CSINAPS Measures of quality of life will include the Alzheimers Disease Related Quality of Life Scale ADRQL and the caregiver-completed Allocation of Caregiver Time Survey ACTS and SF-12 Quality of Life Survey Safety assessment and gastrointestinal tolerability will be based on recording the number and severity of unexpected and undesirable events as well as physical examination and vital signs The exploratory study hypotheses are that galantamine will be superior to donezepil in improving attention sleep patterns and quality of life in patients with mild-to-moderate Alzheimers disease and that it will be well tolerated by patients
Patients will receive either galantamine 4mg twice daily by mouth or donepezil 5mg at bedtime Then either galantamine 8mg twice daily by mouth or donezepil 10 mg at bedtime by mouth with placebo dose the doses are continued into the double-blind extension phase 6 to 54 weeks
Patients will receive either galantamine 4mg twice daily by mouth or donepezil 5mg at bedtime Then either galantamine 8mg twice daily by mouth or donezepil 10 mg at bedtime by mouth with placebo dose the doses are continued into the double-blind extension phase 6 to 54 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None