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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Purimed Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ADM Korea Inc
Information provided by (Responsible Party):
Purimed Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01715350
First received: October 24, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: PM012
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Purimed Co., Ltd.:

Primary Outcome Measures:
  • ADAS-cog [ Time Frame: Week 12 post-dose ] [ Designated as safety issue: No ]
    * 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


Secondary Outcome Measures:
  • ADAS-cog [ Time Frame: Weeks 8 post-dose ] [ Designated as safety issue: No ]
    * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by ADAS-cog at Week 8 post-dose

  • CDR [ Time Frame: Weeks 8 and 12 post-dose ] [ Designated as safety issue: No ]
    * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on overall functional effect assessed by CDR at Weeks 8 and 12 post-dose

  • K-IADL [ Time Frame: Weeks 8 and 12 post-dose ] [ Designated as safety issue: No ]
    * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on activities of daily living assessed by K-IADL at Weeks 8 and 12 post-dose

  • NPI [ Time Frame: Weeks 8 and 12 post-dose ] [ Designated as safety issue: No ]
    * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on behavioral changes assessed by NPI at Weeks 8 and 12 post-dose

  • K-MMSE [ Time Frame: Weeks 8 and 12 post-dose ] [ Designated as safety issue: No ]
    * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on cognitive effect assessed by K-MMSE at Weeks 8 and 12 post-dose

  • VAS [ Time Frame: at Weeks 8 and 12 post-dose ] [ Designated as safety issue: No ]
    * To compare the efficacy of 2 doses of PM012 Tablet and placebo based on improvement on VAS assessed by Senile Dementia Pattern Identification Diagnosis System at Weeks 8 and 12 post-dose

  • AE [ Time Frame: while the subject is receiving the treatment ] [ Designated as safety issue: Yes ]
    * To compare the safety based on treatment-emergent adverse events, laboratory tests (hematology/blood chemistry, urinalysis), physical examination, vital signs


Estimated Enrollment: 126
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group

• 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
  • The drug will be taken with water within 30 minutes after breakfast and supper.
  • 650mg/1 tablet, PO, 12weeks
Other Name: Placebo (for PM012)
Experimental: Dose group 1
  • 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: PM012
  • The drug will be taken with water within 30 minutes after breakfast and supper.
  • 650mg/1 tablet, PO, 12weeks
Other Name: 650-mg PM012 tablet
Drug: Placebo
  • The drug will be taken with water within 30 minutes after breakfast and supper.
  • 650mg/1 tablet, PO, 12weeks
Other Name: Placebo (for PM012)
Experimental: Dose group 2
  • 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
  • The drug will be taken with water within 30 minutes after breakfast and supper.
  • 650mg/1 tablet, PO, 12weeks
Other Name: 650-mg PM012 tablet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715350

Contacts
Contact: Seoung-Hun Cho, M.D. +82-2-958-9186 chosh@khu.ac.kr

Locations
Korea, Republic of
Kyung Hee University Oriental Medicine Hospital Recruiting
Seoul, Dongdaemun-gu, Korea, Republic of, 130-872
Contact: Seoung-Hun Cho, M.D       chosh@khu.ac.kr   
Principal Investigator: Seoung-Hun Cho, M.D.         
Sub-Investigator: Soon Sang Hong, M.S.         
Sub-Investigator: Jae-Eun Lee, B.S.         
Sub-Investigator: Ka-Na Kim, B.S.         
National Health Insurance Corporation Ilsan Hospital Recruiting
Goyang, Ilsandong-gu, Korea, Republic of, 410-719
Contact: Jun-Hong Lee, M.D.       brainleejh@gmail.com   
Principal Investigator: Jun-Hong Lee, M.D.         
Sub-Investigator: Sang-Hyun Lee, M.D.         
Sub-Investigator: Young-Sung Kim, M.D.         
Sub-Investigator: Young-Min Park, M.D.         
The Catholic University of Korea, St. Vincent's Hospital Recruiting
Suwon, Paldal-gu, Korea, Republic of, 442-72
Contact: Hyun-Kook Lim, M.Dd       drblues@catholic.ac.kr   
Principal Investigator: Hyun-Kook Lim, M.D.         
Sub-Investigator: Sang-Uk Song, M.D.         
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Seocho-gu, Korea, Republic of, 137-701
Contact: Chang-Uk Lee, M.D.       jihan@catholic.ac.kr   
Principal Investigator: Chang-Uk Lee, M.D.         
Sub-Investigator: Kyung-Soo Kim, M.D.         
Sub-Investigator: Chang-Tae Hahn, M.D.         
Sponsors and Collaborators
Purimed Co., Ltd.
ADM Korea Inc
Investigators
Principal Investigator: 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. The Catholic University of Korea ST.Vincent's hospital
Principal Investigator: Jun-Hong Lee, M.D. National Health Insurance Service Ilsan Hospital
  More Information

No publications provided

Responsible Party: Purimed Co., Ltd.
ClinicalTrials.gov Identifier: NCT01715350     History of Changes
Other Study ID Numbers: PM012-P2
Study First Received: October 24, 2012
Last Updated: October 25, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Purimed Co., Ltd.:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014