Characteristics of Treatment Responders to Galantamine

January 4, 2016 updated by: Doh Kwan Kim, Samsung Medical Center

Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease

To investigate the characteristics of treatment responders to galantamine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purposes of this study are:

  1. to investigate the characteristics of treatment responders to galantamine by examining the clinical response of galantamine in patients with mild to moderate AD for 52 weeks.
  2. to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
  2. Korean version Mini-Mental State Examination scores between 10 and 26
  3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
  4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

  1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
  2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
  3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
  4. Clinically active cerebrovascular disease; History of seizure disorder
  5. Other physical conditions that required acute treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: non-responder group
patients who did not maintained or improved cognitive function
Drug: galantamine
8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability
Other Names:
  • galantamine-reminyl
Experimental: responder group
patients who maintained or improved cognitive function
Drug: galantamine
8 mg/day (4 mg bid) during the first 4 weeks, up to a maximum of 24 mg/day (12 mg bid) at intervals of 4 weeks, from 16 to 24 mg/day based on the patient's tolerability
Other Names:
  • galantamine-reminyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
Time Frame: baseline, 4w, 13w, 26w, 39w, 52w
baseline, 4w, 13w, 26w, 39w, 52w

Secondary Outcome Measures

Outcome Measure
Time Frame
Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)
Time Frame: baseline, 4w, 13w, 26w, 39w, 52w
baseline, 4w, 13w, 26w, 39w, 52w

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 6, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-04-021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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