Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Normal Saline 0.9%
GV1001 0.56 mg
GV1001 1.12 mg
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring GV1001, Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 55 to 85 years of age
- A patient who satisfies diagnostic criteria for dementia in DSM-IV
- Probable Alzheimer's disease in NINCDS-ADRDA
- K-MMSE ≤ 19 at screening and randomization visit
- GDS 5~6 stage
- MRI or CT scan within 12 months prior to screening visit that proves Alzheimer's disease without any other disease that may cause dementia
- A patient taking stable doses of donepezil for more than 3 months before screening visit
- A patient who are able to visit a hospital (including inpatient and outpatient based) and receive cognitive and other tests
- 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
- Written informed consent by a patient or legal representative
Exclusion Criteria:
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
- Vitamin B12, folic acid, syphilis serology, and thyroid stimulating hormone (TSH) results are thought to contribute to the severity of dementia or cause dementia
- 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)
- 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
- 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
- Hypersensitivity to investigational medicinal products
- History of alcohol, substance abuse or dependence (except nicotine dependence) within the last 2 years
- 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
- Renal impairment (creatinine clearance (CLcr) <30 mL / min)
- Severe liver dysfunction (ALT or AST> 2 times the upper limit of normal)
- A patient taking other drugs other than donepezil to treat Alzheimer's disease or other cognitive impairment
- 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
- 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
- Pregnancy or breast feeding
- A patient who participated in other clinical trials within 4 weeks prior to this study
- 35 kg weight or below
- A patient who had experienced this study drug
- A patient who had participated in a clinical trial for Alzheimer dementia vaccine within last 6 months
- Any other patients who are considered to be ineligible for this study by an investigator
Sites / Locations
- Hanyang University Guri Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control group
Study group 1
Study group 2
Arm Description
Normal saline 0.9%
GV1001 0.56 mg
GV1001 1.12 mg
Outcomes
Primary Outcome Measures
SIB (Severe Impairment Battery)
Change in SIB compared to the baseline and week 24
Secondary Outcome Measures
K-MMSE (Korean-Mini-Mental State Examination)
Change in K-MMSE compared to the baseline and week 24
CDR-SOB (Clinical Dementia Rating-Sum of Box)
Change in CDR-SOB compared to the baseline and week 24
NPI (Neuropsychiatric Inventory)
Change in NPI compared to the baseline and week 24
GDS (Global Deterioration Scale)
Change in GDS compared to the baseline and week 24
ADCS-ADL-severe (Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe)
Change in ADCS-ADL-severe compared to the baseline and week 24
CIBIC-plus (Clinician Interview-Based Impression of Change-Plus)
Change in CIBIC-plus compared to the baseline and week 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03184467
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GemVax & Kael
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
Control group (placebo): 30 subjects
Study group 1 (GV1001 0.56 mg): 30 subjects
Study group 2 (GV1001 1.12 mg): 30 subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
GV1001, Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.9%
Arm Title
Study group 1
Arm Type
Experimental
Arm Description
GV1001 0.56 mg
Arm Title
Study group 2
Arm Type
Experimental
Arm Description
GV1001 1.12 mg
Intervention Type
Drug
Intervention Name(s)
Normal Saline 0.9%
Other Intervention Name(s)
NS 0.9%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GV1001 0.56 mg
Other Intervention Name(s)
Tertomotide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GV1001 1.12 mg
Other Intervention Name(s)
Tertomotide
Intervention Description
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.
Primary Outcome Measure Information:
Title
SIB (Severe Impairment Battery)
Description
Change in SIB compared to the baseline and week 24
Time Frame
week 24
Secondary Outcome Measure Information:
Title
K-MMSE (Korean-Mini-Mental State Examination)
Description
Change in K-MMSE compared to the baseline and week 24
Time Frame
week 24
Title
CDR-SOB (Clinical Dementia Rating-Sum of Box)
Description
Change in CDR-SOB compared to the baseline and week 24
Time Frame
week 24
Title
NPI (Neuropsychiatric Inventory)
Description
Change in NPI compared to the baseline and week 24
Time Frame
week 24
Title
GDS (Global Deterioration Scale)
Description
Change in GDS compared to the baseline and week 24
Time Frame
week 24
Title
ADCS-ADL-severe (Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe)
Description
Change in ADCS-ADL-severe compared to the baseline and week 24
Time Frame
week 24
Title
CIBIC-plus (Clinician Interview-Based Impression of Change-Plus)
Description
Change in CIBIC-plus compared to the baseline and week 24
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
55 to 85 years of age
A patient who satisfies diagnostic criteria for dementia in DSM-IV
Probable Alzheimer's disease in NINCDS-ADRDA
K-MMSE ≤ 19 at screening and randomization visit
GDS 5~6 stage
MRI or CT scan within 12 months prior to screening visit that proves Alzheimer's disease without any other disease that may cause dementia
A patient taking stable doses of donepezil for more than 3 months before screening visit
A patient who are able to visit a hospital (including inpatient and outpatient based) and receive cognitive and other tests
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
Written informed consent by a patient or legal representative
Exclusion Criteria:
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
Vitamin B12, folic acid, syphilis serology, and thyroid stimulating hormone (TSH) results are thought to contribute to the severity of dementia or cause dementia
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)
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
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
Hypersensitivity to investigational medicinal products
History of alcohol, substance abuse or dependence (except nicotine dependence) within the last 2 years
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
Renal impairment (creatinine clearance (CLcr) <30 mL / min)
Severe liver dysfunction (ALT or AST> 2 times the upper limit of normal)
A patient taking other drugs other than donepezil to treat Alzheimer's disease or other cognitive impairment
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
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
Pregnancy or breast feeding
A patient who participated in other clinical trials within 4 weeks prior to this study
35 kg weight or below
A patient who had experienced this study drug
A patient who had participated in a clinical trial for Alzheimer dementia vaccine within last 6 months
Any other patients who are considered to be ineligible for this study by an investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Gon Song, MD., PhD.
Organizational Affiliation
GemVax & Kael
Official's Role
Study Director
Facility Information:
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Gyunggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33771205
Citation
Koh SH, Kwon HS, Choi SH, Jeong JH, Na HR, Lee CN, Yang Y, Lee AY, Lee JH, Park KW, Han HJ, Kim BC, Park JS, Lee JY, Kim S, Lee KY. Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial. Alzheimers Res Ther. 2021 Mar 26;13(1):66. doi: 10.1186/s13195-021-00803-w.
Results Reference
derived
Learn more about this trial
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
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