Phase 4
N=92
The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01054976 ↗Enrolled (actual)
92
Serious AEs
8.7%
Results posted
Dec 2012
Primary outcome: Primary: Change From Baseline in Simple Reaction Time — -30.92; 180.83 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Galantamine (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Janssen Korea, Ltd., Korea
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Simple Reaction Time |
-30.92; 180.83 | — |
| PRIMARY Change From Baseline in Choice Reaction Time |
429.54; 1331 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) |
1.31 | — |
| SECONDARY Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K) |
-1.41 | — |
| SECONDARY Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL) |
1.22 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01054976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.