Characteristics of Treatment Responders to Galantamine

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:

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.

Enrollment: 66 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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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