An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia

Whanin Pharmaceutical Company

Status and phase: Completed; Phase 3

Conditions: Alzheimer Type Dementia

Treatments: Drug: INM-176; Drug: Aricept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01245530

INM-176

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of two fixed dose (1200mg/day, 1600mg/day) of INM-176 (a drug of treating dementia) comparing with donepezil for treatment for patients with Alzheimer type dementia.

Full description

Probable Alzheimer type dementia compare INM-176 1200~1600mg/day with Donepezil 5~10mg/day of safety and efficacy to randomization, multicenter, double-blind, double-dummy, parallel Phase III clinical study.

Enrollment: 280 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age range : 50 ~ 80 years old
2. Informed consent signed and dated by patient or legal representative
3. Subjects diagnosed with Alzheimer's disease according to DSM-IV criteria
4. Subjects diagnosed with probable Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
5. MMSE score 10 to 26
6. CDR(Clinical Dementia Rating) score 1~2 or GDS(Global Deterioration Scale) 3~5 stage
7. Subjects who didn't take any medication for AchEI (donepezil, memantine, galantamin, etc) before treating or can stop medication at least 4 weeks more prior to screening visit
8. Subjects menopause women or her/his spouse consent with contraception during the study period and 90 days after end of study

Exclusion criteria

1. Subjects with psychiatric disorders other than Alzheimer's disease, such as schizophrenia, depression, bipolar disorder, etc
2. Subjects diagnosed or accompanied with Dementia due to other Neurodegenerative disorders (AIDS, syphilis, creutzfeldt-jacob disease, Picks Disease, Huntingtons Disease, Parkinsons disease related dementia)
3. Subjects diagnosed with vascular dementia
4. Subjects diagnosed with stroke within last 3 months prior to screening visit
5. Subjects who have medical history of significant hepatic disease in screening visit (2 ULN≤ALT, AST)
6. Subjects who have medical history of significant renal disease in screening visit (1.5mg/dl≤Serum creatinine)
7. Subjects who have difficult with regulating blood glucose level with anti-diabetes drug (8.0%<HbA1c)
8. Subjects who have medical history of myocardial infarction or arrhythmia
9. Subjects who take warfarin with Atrial fibrillation
10. Pregnant or nursing women
11. Subjects who p0articipated in other clinical trail within last 3 months
12. Subjects who have hypersensitivity to AchEl (acetylcholinesterase inhibitor)
13. Subjects who have unstable clinical laboratory result in screening visit
14. Subjects doubted the pulmonary disease on the chest X-ray in screening visit
15. Subjects considered unsuitable to participate in clinical trail by investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

280 participants in 2 patient groups

Aricept

Active Comparator group

Description:

Intervention: Drug: Aricept

Treatment:

Drug: Aricept

INM-176

Experimental group

Description:

Intervention: Drug: INM-176

Treatment:

Drug: INM-176