Text Size

Characteristics of Treatment Responders to Galantamine

This study has been completed.
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01029132
First received: December 6, 2009
Last updated: April 21, 2011
Last verified: April 2011
History of Changes
  Purpose

To investigate the characteristics of treatment responders to galantamine.


Condition Intervention
Dementia
 Drug: galantamine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K) [ Time Frame: baseline, 4w, 13w, 26w, 39w, 52w ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: April 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: galantamine-reminyl

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029132

Locations
Korea, Republic of
Samsung Medical Center
Seoul, #50 Ilwon-Dong, Kangnam-Gu, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Janssen Korea, Ltd., Korea
Investigators
Principal Investigator: Doh Kwan Kim, PhD, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Doh Kwan Kim, M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01029132     History of Changes
Other Study ID Numbers: 2007-04-021
Study First Received: December 6, 2009
Last Updated: April 21, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Alzheimer's disease
Galantamine
Treatment response
Efficacy
Adverse Event

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Parasympathomimetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013