A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease

NCT01734395 | Completed Results

• 3 other identifiers: CR100958GAL-KOR-024GALALZ4045
• Study Type: observational
• Target: 1,882
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to demonstrate that the change of attention measure is correlated with the changes of caregiver's burden after treatment with galantamine.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Caregiver's Burden in Alzheimer's disease; Galantamine; Razadyne; Reminyl

Outcome Measures

Primary Outcomes (2)

• Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)

  AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.

  Baseline (Week 1 [Day 1]), Week 16

• Change From Baseline at Week 16 in Burden Interview (BI) Scores

  BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.

  Baseline, Week 16

Secondary Outcomes (1)

• Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)

  Baseline, Week 16

Study Arms (1)

Galantamine

Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable).

Drug: Galantamine

Interventions

Galantamine DRUG

This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion.

Also known as: Razadyne, Reminyl

Galantamine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Alzheimer's disease

You may qualify if:

• Alzheimer's disease according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
• Measuring standard: K-MMSE is 10 to 24
• Patient with reliable Guardian

You may not qualify if:

• Patients with brain tumor, nerve syphilis, meningitis, encephalitis, epilepsy
• Major psychiatric patients such as major depression and schizophrenia
• Patients with treatment-resistant gastric and peptic ulcer
• Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease (thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Galantamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research Director
• Organization: Jan-Cil Korea

82 2 2094

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 27, 2012
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 5, 2013
• Results First Posted: August 5, 2013

Record last verified: 2013-08