Characteristics of Treatment Responders to Galantamine

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Drug: galantamine

• Registration Number: NCT01029132
• Lead Sponsor: Samsung Medical Center

Brief Summary

To investigate the characteristics of treatment responders to galantamine.

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 Timeline

• Study Start: 2007-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-12-06
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-responder group	galantamine	patients who did not maintained or improved cognitive function
responder group	galantamine	patients who maintained or improved cognitive function

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of