Mild to Moderate (stage 4 and 5) Alzheimer's Disease MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: GV1001
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Tertomotide
CAS Number: 922174-60-5
Current Sponsor code: A001
Other descriptive name: hTERT (611
Sponsors
GemVax &KAEL Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female participants 55 to 85 years of age (both inclusive) at the time of signing the informed consent. 2. Diagnosis of probable AD based on NINCDS-ADRDA criteria as determined by a neurologist, geriatrician, psychiatrist, or clinician approved by the Sponsor or designee. 3. Mild or moderate dementia as evidenced by MMSE score =13 to =24 at screening (Visit 1). 4. Imaging studies (MRI or CT) within 2 years prior to screening (or at screening) that has findings consistent with AD and without any other disease that may cause dementia. 5. An Aß PET scan or CSF examination performed within 2 years prior to screening (or at screening) with results consistent with the presence of amyloid pathology. 6. If receiving an approved medication for AD (ie, donepezil, galantamine, rivastigmine, memantine, or memantine/donepezil combination product), must be on the medication with a stable dose for at least 12 weeks before the screening visit (dosing should remain stable throughout the study). 7. If receiving an OTC supplement for cognition (eg, gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin), must not be exceeding the recommended dose for at least 12 weeks prior to screening visit. 8. Able to visit the study center and undergo cognitive, functional, and other tests specified in the protocol. 9. Has a caregiver who agrees to accompany the participant, to supervise the participant’s compliance, sees the participant sufficiently to provide meaningful assessment of changes in participant behavior and function over time and provide information on safety and tolerability. 10. A male participant must agree to use a highly effective contraception method 11. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a WOCBP or a WOBCP who agrees to use highly effective contraception method. 12. A WOCBP must have a negative serum pregnancy test at screening (Visit 1) and a negative urine pregnancy test at Visit 2 before randomization, and must use medically accepted means of contraception throughout the study. 13. Written informed consent provided by participant (or legal representative) and caregiver prior to any study-specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Any other cause of dementia shown by MRI/CT findings within 2 years of screening (or at screening) and neurological examination at screening and Day 1 2. Concurrent or history of schizophrenia or bipolar disorder; OR any other 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 or participant safety; OR the presence or history of suicidal attempts or suicidal ideation evidenced by endorsing Items 4 or 5 of the C-SSRS at screening or Day 1, endorsing any suicidal behavior item on the C-SSRS Since Last Visit form on Day 1, or any suicide attempt within 2 years prior to screening. 3. 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. 4. 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. 5. 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. 6. Known allergies, hypersensitivity, or intolerance to GV1001 or similar products or excipients. 7. History of alcohol, substance abuse or dependence as per DSM-V criteria (except nicotine dependence) within the last 2 years. 8. Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for adequately treated non-metastatic basal cell carcinoma or squamous cell carcinoma of skin, in situ carcinoma of the uterine cervix or non-metastatic prostate cancer. 9. 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. 10. Pregnant, breast feeding, or planning a pregnancy or fathering a child while enrolled in the study or for 3 months after the last dose of study treatment. 11. 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 12. Previous treatment with GV1001. 13. Received an investigational product for AD within the last 6 months. 14. Participated in another clinical study within 4 weeks prior to this study. 15. Treated with aducanumab or participated in a clinical study with aducanumab. 16. Renal impairment (creatinine clearance [CrCL] 2 times the upper limit of normal [ULN]). 18. Body weight =35 kg. 19. Resides in a moderate to high dependency continuous care facility (residence in low grade assisted living facility where there is sufficient au
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To evaluate the efficacy of GV1001 (0.56 mg and 1.12 mg) relative to placebo on cognition in participants with mild to moderate AD, as measured by ADAS-cog11 -To evaluate the safety of GV1001 in participants with mild to moderate AD;Secondary Objective: To evaluate the efficacy of GV1001 (0.56 mg and 1.12 mg) relative to placebo on cognition and function in participants with mild to moderate AD, as measured by: •ADAS-cog11 •A-IADL-Q •NPI •MMSE •CDR-SB •ADCS-CGIC/CIBIC Plus •QoL-AD;Primary end point(s): - Change from baseline in ADAS-Cog11 score at Week 52 - Adverse events (AEs), laboratory test results (hematology, serum chemistry, and urinalysis), ECG findings, and vital signs measurements (pulse rate, blood pressure, respiratory rate, body temperature). Suicidal ideation and behavior will be assessed using the Columbia-Suicide Severity Rating Scale (C SSRS);Timepoint(s) of evaluation of this end point: - Week 52 - during study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • Clinical worsening, defined as =4 points change from baseline in the ADAS-cog11 score at Week 12, Week 26, Week 38, and Week 52 • Change from baseline in A-IADL-Q score at Week 12, Week 26, Week 38 and Week 52 • Change from baseline in NPI score at Week 12, Week 26, Week 38, and Week 52 • Change from baseline in MMSE score at Week 12, Week 26, Week 38, and Week 52 • Change from baseline in CDR-SB score at Week 12, Week 26, Week 38, and Week 52 • Change from baseline in ADCS-CGIC/CIBIC-Plus score at Week 12, Week 26, Week 38, and Week 52 • Change from baseline in QoL-AD score at Week 26 and Week 52;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Finland, France, Italy, Netherlands, Poland, Portugal, Spain, United States
Contacts
Public ContactJeongmi Kim
GemVax & KAEL Co., Ltd.
Outcome results
None listed