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OpenTrials
Completed

NCT Number: NCT01029132

Characteristics of Treatment Responders to Galantamine

To investigate the characteristics of treatment responders to galantamine.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

The purposes of this study are:

  • 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.
  • to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: galantamine-reminyl

Primary outcomes

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

    Time frame: 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)

    Time frame: baseline, 4w, 13w, 26w, 39w, 52w

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Janssen Korea, Ltd., Korea

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 9, 2009
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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