| Eligibility |
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
[ß-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.
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