NCT01715350

Brief Summary

The investigators intend to perform exploratory evaluation of the treatment effectiveness and safety of PM012 Tablet of PuriMED Co., Ltd. at 2 doses in Korean patients with mild to moderate dementia of Alzheimer's type. To achieve this, this study aims to compare each dose with placebo control for the efficacy and safety to explore the clinically optimal dose of PM012 Tablet for therapeutic confirmatory (phase 3) clinical studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

October 24, 2012

Last Update Submit

April 15, 2016

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • ADAS-cog

    \* To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 12 post-dose

    Week 12 post-dose

Secondary Outcomes (7)

  • ADAS-cog

    Weeks 8 post-dose

  • CDR

    Weeks 8 and 12 post-dose

  • K-IADL

    Weeks 8 and 12 post-dose

  • NPI

    Weeks 8 and 12 post-dose

  • K-MMSE

    Weeks 8 and 12 post-dose

  • +2 more secondary outcomes

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

• Drug : Placebo 2 tablet The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.

Drug: Placebo

Dose group 1

EXPERIMENTAL

* Drug : Placebo 1 tablet + Study drug 1 tablet * Study drug(650-mg PM012 tablet) The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.

Drug: PM012Drug: Placebo

Dose group 2

EXPERIMENTAL

* Drug : Study drug 2 tablet * Study drug (650-mg PM012 tablet) The drug will be taken with water within 30 minutes after breakfast and supper. Even if no meal is taken, dosing will not be omitted and the drug should be taken with enough amount of water.

Drug: PM012

Interventions

PM012DRUG

* The drug will be taken with water within 30 minutes after breakfast and supper. * 650mg/1 tablet, PO, 12weeks

Also known as: 650-mg PM012 tablet
Dose group 1Dose group 2
PlaceboDRUG

* The drug will be taken with water within 30 minutes after breakfast and supper. * 650mg/1 tablet, PO, 12weeks

Also known as: Placebo (for PM012)
Dose group 1Placebo group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • )Male and female patients aged ≥ 50 and ≤ 85 years
  • )Clinically diagnosed with probable Alzheimer's disease based on DSM-IV and NINCDS-ADRDA criteria
  • )K-MMSE score of 12\~26 at screening visit
  • )For females: 2 years of confirmed menopause or surgical sterilization.
  • )Able to walk (including the use of aids)
  • )Able to perform procedures for cognitive and other tests
  • )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.
  • )Having signed him/herself or his/her legally acceptable representative having signed the written informed consent form

You may not qualify if:

  • )Possible, probable, or definite vascular dementia by NINDS-AIREN criteria
  • )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
  • )Delusion, delirium, epilepsy and other neurological pathology on neurological examination
  • )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
  • )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)
  • )Past history of known or suspected seizures including febrile convulsion, unexplained recent unconsciousness or past history of significant head trauma with unconsciousness.
  • )Gastrointestinal, endocrine and cardiovascular disease not controlled by diet or pharmacologic therapy
  • )Cardiac disease such as myocardial infarction or valvular disease of heart, arrhythmia within 3 months of the study start
  • )Diabetes mellitus not controlled by hypoglycemic agent or insulin-dependent diabetes mellitus
  • )Past history of alcohol or other drug abuse
  • )Having taken acetylcholinesterase inhibitor or memantine within the past 3 months
  • )Hypertension with systolic blood pressure of \> 165 mmHg or diastolic blood pressure of \> 96 mmHg
  • )Severe renal impairment (serum creatinine ≥ 1.7 mg/dl)
  • )Severe hepatic impairment (ALT, AST, or bilirubin ≥ 2.0 x upper limit of normal)
  • )Is taking or expected to take disallowed concomitant medication
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kyung Hee University Oriental Medicine Hospital

Seoul, Dongdaemun-gu, 130-872, South Korea

Location

National Health Insurance Corporation Ilsan Hospital

Goyang, Ilsandong-gu, 410-719, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Paldal-gu, 442-72, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seocho-gu, 137-701, South Korea

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Seoung-Hun Cho, M.D.

    Kyung Hee University Oriental Medicine Hospital

    PRINCIPAL INVESTIGATOR

  • Chang-Uk Lee, M.D.

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Hyun-Kook Lim, M.D.

    Saint Vincent's Hospital, Korea

    PRINCIPAL INVESTIGATOR

  • Jun-Hong Lee, M.D.

    National Health Insurance Service Ilsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 26, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2014

Study Completion

June 1, 2015

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

KR(4)