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Alzheimer DiseasePhase 2NCT03184467

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

A Phase 2 study testing Normal Saline 0.9%, GV1001 0.56 mg and GV1001 1.12 mg in people with Alzheimer Disease, run by GemVax & Kael at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Normal Saline 0.9%, GV1001 0.56 mg and GV1001 1.12 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteSouth Korea
Study dates
5 Sep 2017to 19 Sep 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hanyang University Guri Hospital

    Guri-si, Gyunggi-do, 11923

Other trials in South Korea

About this study

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

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.

Read the 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.
Being tested
Normal Saline 0.9%, GV1001 0.56 mg, GV1001 1.12 mg
Keywords
GV1001, Alzheimer Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal Saline 0.9%Drug

    Also called NS 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.

  • GV1001 0.56 mgDrug

    Also called Tertomotide

    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.

  • GV1001 1.12 mgDrug

    Also called Tertomotide

    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.

Study groups in NCT03184467
Study groupRoleWhat they receive
Control groupPlacebo comparatorNormal saline 0.9%
Receives: Drug: Normal Saline 0.9%
Study group 1ExperimentalGV1001 0.56 mg
Receives: Drug: GV1001 0.56 mg
Study group 2ExperimentalGV1001 1.12 mg
Receives: Drug: GV1001 1.12 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SIB (Severe Impairment Battery)

    Change in SIB compared to the baseline and week 24

    Measured: week 24

Secondary outcomes (6)

  1. K-MMSE (Korean-Mini-Mental State Examination)

    Change in K-MMSE compared to the baseline and week 24

    Measured: week 24

  2. CDR-SOB (Clinical Dementia Rating-Sum of Box)

    Change in CDR-SOB compared to the baseline and week 24

    Measured: week 24

  3. NPI (Neuropsychiatric Inventory)

    Change in NPI compared to the baseline and week 24

    Measured: week 24

  4. GDS (Global Deterioration Scale)

    Change in GDS compared to the baseline and week 24

    Measured: week 24

  5. 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

    Measured: week 24

  6. CIBIC-plus (Clinician Interview-Based Impression of Change-Plus)

    Change in CIBIC-plus compared to the baseline and week 24

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study start5 Sep 2017
  3. Primary completion5 Sep 2019
  4. Study completion19 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03184467
Sponsor's protocol ID
KG 6/2016
Status last verified
Jul 2020
First submitted
9 Jun 2017
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37545861

  • 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.

    PubMed 33771205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Normal Saline 0.9%, GV1001 0.56 mg and GV1001 1.12 mg in people with Alzheimer Disease, run by GemVax & Kael at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SIB (Severe Impairment Battery) (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03184467, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.

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