GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD)

NCT03959553 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: KG7/2017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study is being conducted by the Sponsor to evaluate the efficacy and safety of GV1001 (0.56 mg and 1.12 mg) administered subcutaneously as a treatment for moderate Alzheimer's disease (AD). GV1001 has been shown to inhibit neurotoxicity, apoptosis, and the production of reactive oxygen species induced by amyloid beta in neural stem cells by mimicking the extra-telomeric functions of human telomerase reverse transcriptase (hTERT). In nonclinical studies, using both mild (early stage) and severe (late stage) AD mouse models, GV1001 has been shown to improve cognitive function and memory, as well as significantly reduce the amount of amyloid beta and tau proteins. The multifunctional effect of GV1001 makes it a promising therapeutic option for the treatment for AD.

Conditions

Moderate Alzheimer's Disease

Keywords

Alzheimer's Disease; GV1001

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog)

  The proportion of participants with any improvement in ADAS-cog compared to the baseline and Week 26

  Week 26

Secondary Outcomes (6)

• Alzheimer's Disease Assessment Scale-cognitive (ADAS cog)

  Week 26

• Clinician's Interview-Based Impression of Change (CIBIC)-Plus

  Week 26

• Clinical Dementia Rating - Sum of Boxes (CDR-SB)

  Week 26

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

  Week 26

• Neuropsychiatric Inventory (NPI)

  Week 26

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24

Drug: Normal saline

GV1001 0.56 mg

EXPERIMENTAL

GV1001 0.56 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24

Drug: GV1001

GV1001 1.12 mg

EXPERIMENTAL

GV1001 1.12 mg SC injection administered once weekly for 4 weeks then every 2 weeks through Week 24

Drug: GV1001

Interventions

GV1001 DRUG

Lyophilized peptide from hTERT

Also known as: Tertomotide

GV1001 0.56 mg; GV1001 1.12 mg

Normal saline DRUG

0.9% normal saline

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female participants 55 to 85 years of age, inclusive, at the time of signing the informed consent.
• Diagnosis of probable AD based on NINCDS-ADRDA criteria.
• Diagnosis of dementia based on DSM-V criteria.
• Moderate dementia as evidenced by MMSE score ≥10 to \<20 at screening.
• Magnetic resonance imaging or CT within 12 months prior to randomization with findings consistent with AD and without any other disease that may cause dementia.
• If receiving an FDA-approved medication for AD (ie, donepezil, galantamine, rivastigmine, memantine, or memantine/donepezil combination product) must be on a stable dose for at least 3 months prior to screening visit.
• If receiving an OTC supplement for cognition (eg, gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin) must be taking a stable dose for at least 3 months prior to screening visit.
• Able to visit the study center and undergo cognitive, functional, and other tests specified in the protocol.
• Has a caregiver who:
• Agrees to accompany the participant to all study visits and able to supervise the participant's compliance with the study procedures and provide detailed information about the participant.
• Either lives with the participant or sees the participant on average for ≥1 hours/day ≥3 days/week, or in the Investigator's opinion, the extent of contact is sufficient to provide meaningful assessment of changes in participant behavior and function over time and provide information on safety and tolerability.
• Is able to read, understand, and speak the designated language at the study center.
• Caregiver must be cognitively able to fulfill the requirements of the study.
• A male participant must agree to use a highly effective contraception as detailed in Appendix 4 of this protocol during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:

You may not qualify if:

• Any other cause of dementia shown by MRI/CT findings and neurological examination within 12 months of randomization.
• Possible, probable, or definite vascular dementia according to the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria.
• Evidence of significant abnormality that would suggest another potential etiology for dementia (eg, evidence of cerebral contusion, encephalomalacia, aneurysm, vascular malformation, \>5 microhemorrhages, macrohemorrhage, single infarct \>1cm3).
• Other central nervous system diseases that may cause cognitive impairment (eg, cerebrovascular disease including cerebrovascular dementia, Parkinsonism, Huntington's disease, subdural hematoma, normal pressure hydrocephalus, brain tumor, Creutzfeldt-Jakob disease).
• Concurrent or history of clinically significant psychiatric conditions (eg. Schizophrenia or bipolar affective disorder) that in the Investigator's opinion prevents the participant from participating, or is likely to confound interpretation of drug effect or affect cognitive assessments.
• Vitamin B12, folic acid, syphilis serology, and thyroid stimulating hormone (TSH) results that are thought to contribute to the severity of dementia or cause dementia. Participants may be enrolled if in the Investigator's medical judgment the abnormal laboratory values are not the cause of the cognitive symptoms.
• History of known or suspected seizures including febrile seizures (excluding self-limited childhood febrile seizures), a history of significant head trauma with loss of consciousness or recent unconsciousness that is not explained.
• 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 the clinical study.
• Known allergies, hypersensitivity, or intolerance to GV1001 or similar products or excipients.
• History of alcohol, substance abuse or dependence as per DSM-V criteria (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
• Sexually-active WOCBP or man capable of fathering a child who do not consent to using medicinally acceptable contraception (such as surgical sterilization, intrauterine contraceptive device, condom or diaphragm, an injectable or inserted contraceptive) during the study and for 3 months after the last dose of study treatment.
• Pregnant, breast feeding, or planning a pregnancy or fathering a child while enrolled in the study or for 3 months after the las dose of study treatment.
• Use of anxiolytics, narcotics, or sleep aids in a manner that would interfere with cognitive testing, in the opinion of the Investigator. Atypical antipsychotics may be used at the discretion of the Investigator. Tricyclic antidepressants and monoamine oxidase (MAO) inhibitors are prohibited.
• Previous treatment with GV1001.

Sponsors & Collaborators

• GemVax & Kael: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

GV1001 peptide; 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 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: May 8, 2019
• First Posted: May 22, 2019
• Study Start: September 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: February 28, 2022
• Last Updated: March 3, 2022

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share