ADD

CompletedPhase 2

Study to Explore the Optimal Dosage/Administration in Alzheimer's Disease

A Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease: Double-Blind, Randomized Between Placebo Control Group and Dose Groups, Parallel-Design, Multicenter Study

Lead sponsor

VTBIO Co. LTD

Asset

PM012

Listed sites

Recruiting sites

Enrollment

151

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12

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

NCT IDNCT01715350

Org study IDPM012-P2

Timeline

Milestones

Study start2012-05 (month precision)

Study first posted2012-10-26estimated

Primary completion2014-09actual (month precision)

Study completion2015-06actual (month precision)

Last update posted2016-04-18estimated

Assets

Drug assets

PM012

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1)Male and female patients aged ≥ 50 and ≤ 85 years

•2)Clinically diagnosed with probable Alzheimer's disease based on DSM-IV and NINCDS-ADRDA criteria

•3)K-MMSE score of 12~26 at screening visit

•4)For females: 2 years of confirmed menopause or surgical sterilization.

•5)Able to walk (including the use of aids)

•6)Able to perform procedures for cognitive and other tests

•7)Residing with a life-long guardian willing to accompany the subject's on all visits, oversee his/her compliance with the procedures specified in the protocol and the study drug, and report his/her condition.

•8)Having signed him/herself or his/her legally acceptable representative having signed the written informed consent form

Exclusion criteria

•1)Possible, probable, or definite vascular dementia by NINDS-AIREN criteria

•2)History and/or evidence (result of CT or MRI performed within the past 12 months or at screening) of other CNS disease (cerebrovascular disease, structural or developmental anomaly, epilepsy, contagious, degenerative or infectious/demyelinating CNS condition) as a cause of dementia

•3)Delusion, delirium, epilepsy and other neurological pathology on neurological examination

•4)Abnormal test result on vitamin B12, syphilis serology, and thyroid stimulating hormone (TSH) tests that are thought to contribute to the subject's dementia severity or be a cause of dementia

•5)History of significant psychiatric disease such as schizophrenia or bipolar affective disorder that may interfere with the participation in this study in the opinion of the investigator, or current depression (GDS ≥ 18)

•6)Past history of known or suspected seizures including febrile convulsion, unexplained recent unconsciousness or past history of significant head trauma with unconsciousness.

•7)Gastrointestinal, endocrine and cardiovascular disease not controlled by diet or pharmacologic therapy

•8)Cardiac disease such as myocardial infarction or valvular disease of heart, arrhythmia within 3 months of the study start

•9)Diabetes mellitus not controlled by hypoglycemic agent or insulin-dependent diabetes mellitus

•10)Past history of alcohol or other drug abuse

•11)Having taken acetylcholinesterase inhibitor or memantine within the past 3 months

•12)Hypertension with systolic blood pressure of > 165 mmHg or diastolic blood pressure of > 96 mmHg

•13)Severe renal impairment (serum creatinine ≥ 1.7 mg/dl)

•14)Severe hepatic impairment (ALT, AST, or bilirubin ≥ 2.0 x upper limit of normal)

•15)Is taking or expected to take disallowed concomitant medication

•16)History of clinically significant drug hypersensitivity

•17)Is ineligible to participate in this study in the judgment of the investigator

Endpoints (8)

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

Other (unclassified)

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Global cognition

3 endpoints

Primary/protocol endpoint

ADAS-cog

Time frame:Week 12 post-dose

ADAS-Cog

descriptive

Secondary/protocol endpoint

ADAS-cog

Time frame:Weeks 8 post-dose

ADAS-Cog

descriptive

Secondary/protocol endpoint

K-MMSE

Time frame:Weeks 8 and 12 post-dose

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

K-IADL

Time frame:Weeks 8 and 12 post-dose

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

NPI

Time frame:Weeks 8 and 12 post-dose

Neuropsychiatric Inventory (NPI)

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Time frame:while the subject is receiving the treatment

event count, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

CDR

Time frame:Weeks 8 and 12 post-dose

descriptive

Secondary/protocol endpoint/low confidence

VAS

Time frame:at Weeks 8 and 12 post-dose

categorical status, descriptive

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.