Characteristics of Treatment Responders to Galantamine

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Samsung Medical Center

Status

Completed

Conditions

Dementia

Treatments

Drug: galantamine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01029132
2007-04-021

Details and patient eligibility

About

To investigate the characteristics of treatment responders to galantamine.

Full description

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.

Enrollment

66 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

66 participants in 2 patient groups

non-responder group
Experimental group
Description:
patients who did not maintained or improved cognitive function
Treatment:
Drug: galantamine
responder group
Experimental group
Description:
patients who maintained or improved cognitive function
Treatment:
Drug: galantamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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