Characteristics of Treatment Responders to Galantamine

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01029132

Enrollment

Registered

2009-12-09

Start date

2007-04-30

Completion date

2009-10-31

Last updated

2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

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

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.

Interventions

DRUGgalantamine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026