The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia:

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life.

Clinical Trial Description

A double-blind (neither the patient nor the physician know the name of the study drug), 6-month, multicenter, placebo-controlled trial to evaluate the combination of galantamine with nimodipine in patients with mixed dementia on cognition and quality of life. The target dose of galantamine is 24 mg/day and nimodipine will be taken in fixed doses of 90 mg/day. Primary outcomes will be measured by a computerized battery of neuropsychological tests and Quality of Life (QoL) scores. Secondary outcomes will be measured by ADAS-cog, Clinical Global Impression (CGI) and Neuropsychiatric Inventory (NPI). Mixed dementia (Alzheimer's Disease (AD) associated with cerebrovascular disease) is one of the most common causes of dementia, which remain largely underdiagnosed. Little is known about specific treatments for this condition. Ischemic lesions by themselves seem to play an important role in cognitive impairment, even in the presence of AD pathology. Hypotheses: - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) in improving or stabilizing cognition in patients with AD associated with cerebrovascular disease (mixed dementia), as measured by the CNTB at 6 months. - Galantamine 16-24 mg/day in combination with nimodipine 90 mg/day is superior to galantamine monotherapy (16-24 mg/day) on QoL measures in this population as measured by QoL - AD at 6 months. Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus nimodipine oral 30mg tid during all study. Group 2: Group 1: galantamine oral 8mg/day for a month, 16mg/day for 4 weeks and after 24mg/day until end of study plus placebo oral 30mg tid during all study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Dementia

Clinical Trial Details

NCT number	NCT00814658
Study type	Interventional
Source	Janssen-Cilag Farmaceutica Ltda.
Contact
Status	Completed
Phase	Phase 4
Start date	June 2008
Completion date	October 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05686486` - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes	N/A
Terminated	`NCT05451693` - Outreach-ER: A Dementia Care Intervention Program
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Enrolling by invitation	`NCT06040294` - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills	N/A
Completed	`NCT05114187` - An Internet-Based Education Program for Care Partners of People Living With Dementia	N/A
Recruiting	`NCT06322121` - Vascular Aspects in Dementia: Part 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed	`NCT04426838` - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad	N/A
Recruiting	`NCT03462485` - Pilot Study of the Effects of Playing Golf on People With Dementia	N/A
Active, not recruiting	`NCT03677284` - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia	N/A
Completed	`NCT03849937` - Changing Talk Online (CHATO) Study	N/A
Recruiting	`NCT06284213` - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting	`NCT05579236` - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed	`NCT05080777` - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems	N/A
Completed	`NCT04571697` - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed	`NCT03583879` - Using Gait Robotics to Improve Symptoms of Parkinson's Disease	N/A
Recruiting	`NCT06033066` - Financial Incentives and Recruitment to the APT Webstudy	N/A
Active, not recruiting	`NCT05204940` - Longitudinal Observational Biomarker Study
Recruiting	`NCT05684783` - Dementia Champions in Homecare
Completed	`NCT03147222` - Function Focused Care: Fracture Care at Home	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Use of Galantamine (Reminyl ER) in Patients With MIXed Dementia: Effects on Cognition and Quality of Life

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms