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Trial record 3 of 14 for:    GV1001

Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03184467
Recruitment Status : Unknown
Verified June 2017 by GemVax & Kael.
Recruitment status was:  Recruiting
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
GemVax & Kael

Brief Summary:

This clinical study is designed as a multi-center, randomized, double-blind, placebo-controlled, parallel design, prospective, phase II clinical trial.

An eligible subject who meets inclusion and exclusion criteria is randomly assigned to three groups: study group 1 (GV1001 0.56 mg), study group 2 (GV1001 1.12 mg) or placebo group. A randomized subject is administered either GV1001 or placebo in a total of 14 times and will be evaluated for the efficacy and safety at week of 24.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Normal Saline 0.9% Drug: GV1001 0.56 mg Drug: GV1001 1.12 mg Phase 2

Detailed Description:

GV1001 0.56 mg, 1.12 mg or placebo is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.

  1. Control group (placebo): 30 subjects
  2. Study group 1 (GV1001 0.56 mg): 30 subjects
  3. Study group 2 (GV1001 1.12 mg): 30 subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Design, Prospective, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Donepezil and Combined With GV1001 in Alzheimer Patients
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
Normal saline 0.9%
Drug: Normal Saline 0.9%
Normal saline 0.9% is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
Other Name: NS 0.9%

Experimental: Study group 1
GV1001 0.56 mg
Drug: GV1001 0.56 mg
GV1001 0.56 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
Other Name: Tertomotide

Experimental: Study group 2
GV1001 1.12 mg
Drug: GV1001 1.12 mg
GV1001 1.12 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
Other Name: Tertomotide




Primary Outcome Measures :
  1. SIB (Severe Impairment Battery) [ Time Frame: week 24 ]
    Change in SIB compared to the baseline and week 24


Secondary Outcome Measures :
  1. K-MMSE (Korean-Mini-Mental State Examination) [ Time Frame: week 24 ]
    Change in K-MMSE compared to the baseline and week 24

  2. CDR-SOB (Clinical Dementia Rating-Sum of Box) [ Time Frame: week 24 ]
    Change in CDR-SOB compared to the baseline and week 24

  3. NPI (Neuropsychiatric Inventory) [ Time Frame: week 24 ]
    Change in NPI compared to the baseline and week 24

  4. GDS (Global Deterioration Scale) [ Time Frame: week 24 ]
    Change in GDS compared to the baseline and week 24

  5. ADCS-ADL-severe (Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe) [ Time Frame: week 24 ]
    Change in ADCS-ADL-severe compared to the baseline and week 24

  6. CIBIC-plus (Clinician Interview-Based Impression of Change-Plus) [ Time Frame: week 24 ]
    Change in CIBIC-plus compared to the baseline and week 24



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 55 to 85 years of age
  2. A patient who satisfies diagnostic criteria for dementia in DSM-IV
  3. Probable Alzheimer's disease in NINCDS-ADRDA
  4. K-MMSE ≤ 19 at screening and randomization visit
  5. GDS 5~6 stage
  6. MRI or CT scan within 12 months prior to screening visit that proves Alzheimer's disease without any other disease that may cause dementia
  7. A patient taking stable doses of donepezil for more than 3 months before screening visit
  8. A patient who are able to visit a hospital (including inpatient and outpatient based) and receive cognitive and other tests
  9. A patient with a caregiver who can accompany all visits and supervise the subject's compliance with the procedures and study drug prescribed in the protocol, and provide detailed information about the patient
  10. Written informed consent by a patient or legal representative

Exclusion Criteria:

  1. Any other cause of dementia shown by CT / MRI findings and neurological examination within 12 months of screening visit

    • Possible, probable or definite vascular dementia according to the NINDS-AIREN
    • Other central nervous system diseases that may cause cognitive impairment (cerebrovascular disease including cerebrovascular dementia, Parkinsonism, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, Creutzfeldt-Jakob disease, etc.)
    • Neurological deficits such as delusions, delirium, epilepsy
  2. Vitamin B12, folic acid, syphilis serology, and thyroid stimulating hormone (TSH) results are thought to contribute to the severity of dementia or cause dementia
  3. A patient who are considered ineligible for this study by investigator due to concurrent or history of significant psychiatric conditions (eg. schizophrenia or bipolar affective disorder)
  4. A patient with a history of known or suspected seizures including febrile seizures, a history of significant head trauma with loss of consciousness or recent unconsciousness that is not explained
  5. A patient with acute or unstable cardiovascular disease, active peptic ulcer, uncontrolled hypertension, uncontrolled diabetes or insulin dependent patients or any medical condition that may interfere with the completion of clinical trials
  6. Hypersensitivity to investigational medicinal products
  7. History of alcohol, substance abuse or dependence (except nicotine dependence) within the last 2 years
  8. Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for non-metastatic basal cell carcinoma or squamous cell carcinoma of skin, in situ carcinoma of the uterine cervix or non-metastatic prostate cancer
  9. Renal impairment (creatinine clearance (CLcr) <30 mL / min)
  10. Severe liver dysfunction (ALT or AST> 2 times the upper limit of normal)
  11. A patient taking other drugs other than donepezil to treat Alzheimer's disease or other cognitive impairment
  12. A patient taking other drugs other than anticholinergic drugs, cholinergic drugs (local usages are allowable, such as pilocarpine eye drops), antidepressants (tricyclic antidepressant, MAO inhibitor) antipsychotics, donepezil to treat Alzheimer's disease
  13. Women at childbearing age who do not consent using medicinally acceptable contraception (such as surgical sterilization, intrauterine contraceptive device, condom or diaphragm, an injectable or inserted contraceptive) during the study
  14. Pregnancy or breast feeding
  15. A patient who participated in other clinical trials within 4 weeks prior to this study
  16. 35 kg weight or below
  17. A patient who had experienced this study drug
  18. A patient who had participated in a clinical trial for Alzheimer dementia vaccine within last 6 months
  19. Any other patients who are considered to be ineligible for this study by an investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184467


Contacts
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Contact: Moonhwan Do, Bachelor +82 70 4367 2714 mdo@gemvax.com
Contact: Jaeyoung Park, Bachelor +82 70 4738 9721 jypark@kaelgemvax.com

Locations
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Korea, Republic of
Hanyang University Guri Hospital Recruiting
Guri-si, Gyunggi-do, Korea, Republic of, 11923
Contact: Seong-Ho Koh, MD, PhD.       ksh213@hanyang.ac.kr   
Sponsors and Collaborators
GemVax & Kael
Investigators
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Study Director: Hyoung Gon Song, MD., PhD. GemVax & Kael

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Responsible Party: GemVax & Kael
ClinicalTrials.gov Identifier: NCT03184467    
Other Study ID Numbers: KG 6/2016
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GemVax & Kael:
GV1001
Alzheimer Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders