The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease

NCT01054976 | Completed Phase 4 Results

• 3 other identifiers: CR015850GAL-KOR-21GALALZ4039
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Galantamine; Dementia

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Simple Reaction Time

  The Simple Reaction Time is a computerized attention test that evaluates the patient's reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.

  Baseline, Week 12

• Change From Baseline in Choice Reaction Time

  The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.

  Baseline, Week 12

Secondary Outcomes (3)

• Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

  Baseline, Week 12

• Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)

  Baseline, Week 12

• Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)

  Baseline, Week 12

Study Arms (1)

Galantamine

EXPERIMENTAL

Drug: Galantamine

Interventions

Galantamine DRUG

Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day.

Galantamine

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA
• K-MMSE (Korean - Mini Mental State Exam) is 10 to 24
• Reliable Guardian available to the patients
• Patient or guardian provided written informed consent before entering into the clinical trial

You may not qualify if:

• Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial
• Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
• Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
• brain tumor, nerve syphilis, meningitis, encephalitis
• epilepsy

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Galantamine

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

A relatively low number of patients finished the study, which may have had an impact on the statistical power of data analysis. Difficulties in performing computer-based tests for elderly patients may have hampered detection of changes in attention.

Results Point of Contact

• Title: Business Unit Director
• Organization: Jan-Cil Korea

82 2 2094-4537

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: October 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 24, 2012
• Results First Posted: December 24, 2012

Record last verified: 2012-11