Characteristics of Treatment Responders to Galantamine

NCT01029132 | Completed DMC

• 1 other identifier: 2007-04-021
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the characteristics of treatment responders to galantamine.

Conditions

Dementia

Keywords

Alzheimer's disease; Galantamine; Treatment response; Efficacy; Adverse Event

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)

  baseline, 4w, 13w, 26w, 39w, 52w

Secondary Outcomes (1)

• 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

Study Arms (2)

non-responder group

EXPERIMENTAL

patients who did not maintained or improved cognitive function

Drug: galantamine

responder group

EXPERIMENTAL

patients who maintained or improved cognitive function

Drug: galantamine

Interventions

galantamine DRUG

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

Also known as: galantamine-reminyl

non-responder group; responder group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Janssen Korea, Ltd., Korea: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Doh Kwan Kim, PhD, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2009
• First Posted: December 9, 2009
• Study Start: April 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 6, 2016

Record last verified: 2016-01

Locations

KR (1)