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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

December 6, 2009
April 21, 2011
April 2007
October 2009   (final data collection date for primary outcome measure)
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 ]
ADAS-Cog-K [ Time Frame: baseline, 4w, 13w, 26w, 39w, 52w ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01029132 on ClinicalTrials.gov Archive Site
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 ]
S-ADL, S-IADL, K-NPI [ Time Frame: baseline, 4w, 13w, 26w, 39w, 52w ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Characteristics of Treatment Responders to Galantamine
Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease

To investigate the characteristics of treatment responders to galantamine.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dementia
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: non-responder group
    patients who did not maintained or improved cognitive function
    Intervention: Drug: galantamine
  • Experimental: responder group
    patients who maintained or improved cognitive function
    Intervention: Drug: galantamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01029132
2007-04-021
Yes
Doh Kwan Kim, M.D., Ph.D., Samsung Medical Center
Samsung Medical Center
Janssen Korea, Ltd., Korea
Principal Investigator: Doh Kwan Kim, PhD, M.D. Samsung Medical Center
Samsung Medical Center
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP