Characteristics of Treatment Responders to Galantamine

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029132
• Other study ID #: 2007-04-021
• Status: Completed
• Phase: N/A
• First received: December 6, 2009
• Last updated: January 4, 2016
• Start date: April 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To investigate the characteristics of treatment responders to galantamine.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia

Intervention

Drug:
• galantamine
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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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