The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Alzheimer's Disease

Treatments

Drug: Galantamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01054976

CR015850

GALALZ4039 (Other Identifier)

GAL-KOR-21 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

99 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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