N/A
Completed N=1,882
A Study to Show That the Change of Attention Measure is Correlated With the Changes of Caregiver's Burden After Treatment With Galantamine in Patients With Alzheimer's Disease
Source: ClinicalTrials.gov NCT01734395 ↗Enrolled (actual)
1,882
Serious AEs
0.4%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) — -1.19 Units on a scale — p=<.0001
Summary
The purpose of this study is to demonstrate that the change of attention measure is correlated with the changes of caregiver's burden after treatment with galantamine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) |
-1.19 | <.0001 sig |
| PRIMARY Change From Baseline at Week 16 in Burden Interview (BI) Scores |
1.48 | <.0001 sig |
| SECONDARY Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) |
-0.69 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Alzheimer's disease according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- Measuring standard: K-MMSE is 10 to 24
- Patient with reliable Guardian
Exclusion Criteria
- Patients with brain tumor, nerve syphilis, meningitis, encephalitis, epilepsy
- Major psychiatric patients such as major depression and schizophrenia
- Patients with treatment-resistant gastric and peptic ulcer
- Patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease (thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)
Data sourced from ClinicalTrials.gov (NCT01734395). 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. Informational only — not medical advice.