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CompletedPhase 3

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

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

Assets

Donepezil / INM-176

Listed sites

1

Recruiting sites

-

Enrollment

280

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE 10-26

Primary endpoint

ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDINM-176
NCT IDNCT01245530

Timeline

Milestones

Study start2008-06 (month precision)
Study first posted2010-11-22estimated
Primary completion2011-02actual (month precision)
Study completion2011-03actual (month precision)
Last update posted2011-06-13estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
3
Behavior / neuropsychiatric
1
Disease progression
1
Other (unclassified)
1

Global cognition

3 endpoints
Primary/protocol endpoint

Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score

Time frame:up to 24 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to endpoint in Mini-Mental State Examination (MMSE)

Time frame:up to 24 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline to endpoint in Clinical Dementia Rating

Time frame:up to 24 weeks

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change from baseline to endpoint in Korean Neuropsychiatric Inventory (NPI)

Time frame:up to 24 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Disease progression

1 endpoint
Secondary/protocol endpoint

Change from baseline to endpoint in Global Deterioration Scale(GDS)

Time frame:up to 24 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline to endpoint in Korean Activity of Living(K-IADL)

Time frame:up to 24 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.