Clinical trial NCT01054976: The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Official title: The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Galantamine
Dementia
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine whether the administration of galantamine is effective for improvement of attention and more effective for patients with serious disturbance of attention by administering galantamine to patients with Alzheimer's dementia and performing an attention test on baseline, week 4 and 12.

Detailed description: This is an open label (all people know the identity of the intervention), multi-center, prospective study investigating the effect of galantamine on the attention of Alzheimer's dementia patients. The objectives of this study include the evaluation of the relationship between change in attention after 4 weeks of galantamine administration and to investigate the effect of study drug after 12 weeks administration (the difference in the improvement of attention after the administration of galantamine). The secondary objective of this study is to clarify the causal relationship between improvement of attention and activities of daily living (ADL). The design of this study is prospective, open-label, multi-center study. Study populations are probable Alzheimer's dementia patients diagnosed by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association), DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria. The efficacy of study drug will be assessed by evaluating cognitive function, attention and behavioral symptoms before and after the treatment using the following assessment tools: ADAS-K-cog11 (Alzheimer's Disease Assessment Scale - cognitive subscale), computerized attention test and activities of daily living. Safety evaluations include adverse event monitoring and clinical lab tests. The patient is administered oral galantamine 8 mg/day for the first 4 weeks and then 16 mg/day. The dose of galantamine is increased up to 24 mg if tolerated.

Eligibility criteria: Inclusion Criteria:

* Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA
* K-MMSE (Korean - Mini Mental State Exam) is 10 to 24
* Reliable Guardian available to the patients
* Patient or guardian provided written informed consent before entering into the clinical trial

Exclusion Criteria:

* Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial
* Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
* Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
* brain tumor, nerve syphilis, meningitis, encephalitis
* epilepsy

Primary outcomes:
measure: Change From Baseline in Simple Reaction Time
timeFrame: Baseline, Week 12
measure: Change From Baseline in Choice Reaction Time
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: