Clinical trial: GV1001 Subcutaneous(SC) for the Treatment of Moderate Alzheimer's Disease (AD) (NCT03959553)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female participants 55 to 85 years of age, inclusive, at the time of signing
             the informed consent.

          2. Diagnosis of probable AD based on NINCDS-ADRDA criteria.

          3. Diagnosis of dementia based on DSM-V criteria.

          4. Moderate dementia as evidenced by MMSE score ≥10 to <20 at screening.

          5. 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.

          6. 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.

          7. 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.

          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 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.

         10. 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.

         11. 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:

               -  Not a woman of childbearing potential (WOCBP) as defined in Appendix 4. OR

               -  A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the
                  treatment period and for at least 3 months after the last dose of study
                  treatment.

         12. A WOCBP must have a negative serum pregnancy test (beta human chorionic gonadotropin
             [β-hCG]) at screening and a negative urine pregnancy test at Visit 2 before
             randomization.

         13. Written informed consent provided by participant or legal representative and caregiver
             prior to any study-specific procedures.

        Exclusion Criteria:

          1. 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).

          2. 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.

          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 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 las 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 last 6 months.

         14. Participated in another clinical study within 4 weeks prior to this study.

         15. Renal impairment (creatinine clearance [CrCL] <30 mL/min).

         16. Severe liver dysfunction (alanine aminotransferase [ALT] or aspartate aminotransferase
             [AST] >2 times the upper limit of normal [ULN]).

         17. Body weight ≤35 kg.

         18. Resides in a moderate to high dependency continuous care facility (residence in low
             grade assisted living facility where there is sufficient autonomy to permit valid
             evaluation of activities of daily living is allowed).

         19. Any other reason that in the opinion of the Investigator would make the participant
             ineligible to participate or to complete this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment