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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01245530
• Date of registration: 01/11/2010
• Prospective Registration: No
• Primary sponsor: Whanin Pharmaceutical Company
• Public title: An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia
• Scientific title: 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
• Date of first enrolment: June 2008
• Target sample size: 280
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01245530
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Korea, Republic of

Contacts

• Name: SangYoon Kim, MD
• Affiliation: Seoul National University Bundang Hospital

Key inclusion & exclusion criteria

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%
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



Age minimum: 50 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer Type Dementia

Intervention(s)

Drug: INM-176

Drug: Aricept

Primary Outcome(s)

Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score [Time Frame: up to 24 weeks]

Secondary Outcome(s)

Change from baseline to endpoint in Clinical Dementia Rating [Time Frame: up to 24 weeks]

Change from baseline to endpoint in Mini-Mental State Examination (MMSE) [Time Frame: up to 24 weeks]

Change from baseline to endpoint in Global Deterioration Scale(GDS) [Time Frame: up to 24 weeks]

Change from baseline to endpoint in Korean Activity of Living(K-IADL) [Time Frame: up to 24 weeks]

Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI) [Time Frame: up to 24 weeks]

Secondary ID(s)

INM-176

Source(s) of Monetary Support

Please refer to primary and secondary sponsors