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

NCT03184467 | Completed Phase 2

• 1 other identifier: KG 6/2016
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

GV1001; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• SIB (Severe Impairment Battery)

  Change in SIB compared to the baseline and week 24

  week 24

Secondary Outcomes (6)

• K-MMSE (Korean-Mini-Mental State Examination)

  week 24

• CDR-SOB (Clinical Dementia Rating-Sum of Box)

  week 24

• NPI (Neuropsychiatric Inventory)

  week 24

• GDS (Global Deterioration Scale)

  week 24

• ADCS-ADL-severe (Alzheimer's Disease Cooperative Study-Activities of Daily Living scale-severe)

  week 24

Study Arms (3)

Control group

PLACEBO COMPARATOR

Normal saline 0.9%

Drug: Normal Saline 0.9%

Study group 1

EXPERIMENTAL

GV1001 0.56 mg

Drug: GV1001 0.56 mg

Study group 2

EXPERIMENTAL

GV1001 1.12 mg

Drug: GV1001 1.12 mg

Interventions

Normal Saline 0.9% DRUG

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.

Also known as: NS 0.9%

Control group

GV1001 0.56 mg DRUG

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.

Also known as: Tertomotide

Study group 1

GV1001 1.12 mg DRUG

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.

Also known as: Tertomotide

Study group 2

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GemVax & Kael: lead

Study Sites (1)

Hanyang University Guri Hospital

Guri-si, Gyunggi-do, 11923, South Korea

Location

Related Publications (2)

• Kwon HS, Koh SH, Choi SH, Jeong JH, Na HR, Lee CN, Yang Y, Lee AY, Lee JH, Park KW, Han HJ, Kim BC, Park J, Lee JY, Lee KY, Kim S. Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales. Dement Neurocogn Disord. 2023 Jul;22(3):100-108. doi: 10.12779/dnd.2023.22.3.100. Epub 2023 Jul 11.

  PMID: 37545861 DERIVED

• 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.

  PMID: 33771205 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hyoung Gon Song, MD., PhD.

  GemVax & Kael

  STUDY DIRECTOR

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: June 9, 2017
• First Posted: June 12, 2017
• Study Start: September 5, 2017
• Primary Completion: September 5, 2019
• Study Completion: September 19, 2019
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

KR (1)