A randomized, placebo-controlled, double-blind, parallel-group Phase 2a exploratory study with placebo run-in to investigate PK/PD effects, safety, tolerability and pharmacokinetics of REM0046127 oral suspension compared with placebo in subjects with mild to moderate Alzheimer's disease

1. Mild to moderate AD as characterized by the following clinical, cognitive,
and functional criteria.
a. Biomarker profile reflecting AD, according to The National Institute on
Aging*Alzheimer's Association (NIA-AA) Research Framework based on Screening
CSF Aβ1-42 and p-tau concentrations
b. Clear EEG deficit as assessed by the EEG reader
c. MMSE score above 12 (preferably above 16) and a maximum of 24
2. A brain imaging study, such as magnetic resonance imaging (MRI) and/or
computed tomography (CT) scan having been performed within last 6 months from
day of the Screening visit or during the Screening phase of this study
consistent with the clinical diagnosis of AD and excluding other potential
causes of dementia. If there has been a significant change in clinical status
suggestive of stroke or other possible central neurological disease with onset
between the time of the last MRI or CT and the Screening evaluation, an MRI
scan should be repeated during Screening procedures if considered appropriate
by the Investigator
3. Age 50 to 85
4. BMI above 18 and below 30 kg/m2
5. If taking concomitant medications, treated with stable doses of drugs
essentially required for chronic medical conditions which do not lead to
exclusion, during a period of at least 3 months prior to screening, and dose
regimen is expected to remain stable during the conduct of the study
6. If taking an approved cholinesterase inhibitor or NMDA antagonist for
treatment of Alzheimer*s disease, treated with a stable dose for at least 6
months prior to the screening visit and the dose is not expected to change
during the study as per investigators judgement, or must be off such Alzheimer
medication for a period of 8 weeks prior to screening
7. Willing and able to give informed consent.
8. Have a caregiver who assists the participant every day and has intimate
knowledge of the participant*s cognitive, functional, and emotional states and
of the participant*s personal care. The caregiver must be willing to accompany
the participant to all study visits and to supervise IMP administration as well
as report adverse events. The caregiver must be willing and able to give
informed consent for their own participation and be able to read and write
9. Be able to read, write, speak clearly for the cognitive tests, with eyesight
and hearing sufficient to enable completion of the cognitive tests

Subjects are excluded from the study if any of the following criteria apply:
1. COVID-19 positive test at the screening visit
2. Clinical, laboratory or neuro-imaging findings consistent with:
i. Other primary degenerative dementia, (dementia with Lewy bodies,
fronto-temporal dementia, Huntington*s disease, Creutzfeldt-Jakob Disease,
Down*s syndrome, etc.)
ii. Other neurodegenerative condition (Parkinson*s disease, amyotrophic lateral
sclerosis, etc.)
iii. Cerebrovascular disease (major infarct, one strategic or multiple lacunar
infarcts, extensive white matter lesions > one quarter of the total white
matter)
iv. Other central nervous system diseases (severe head trauma, tumors, subdural
hematoma or other space occupying processes, etc.)
v. Seizure disorder
vi. Other infectious, metabolic or systemic diseases affecting central nervous
system (syphilis, present hypothyroidism, present vitamin B12 or folate
deficiency, serum electrolytes out of normal range, juvenile onset diabetes
mellitus, etc.)
3. Current presence of a clinically significant major psychiatric disorder
according to the criteria of the DSM-IV, or symptom that could affect the
subject's ability to complete the study
4. Current clinically significant systemic illness, e.g., neoplasia, that is
likely to result in deterioration of the subject's condition or affect the
subject's safety during the study
5. History of liver disease, including Gilbert*s disease or alcohol abuse
6. Active liver disease or jaundice, or out-of-range values of alanine
aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin,
gamma-glutamyl transferase (GGT), Alkaline Phosphatase (ALP) and/or lactate
dehydrogenase (LDH)
7. History of severe post-lumbar puncture syndrome
8. Abnormalities in the blood clotting system or abnormal coagulation status
9. Women of childbearing potential.
Refer to Appendix X for the definitions of woman of nonchildbearing potential.
10. Male subjects with female partners of child-bearing potential who are
unwilling or unable to adhere to contraception requirements
11. Participation in another clinical study during the last 3 months
12. Wheelchair-bound or bed-ridden
13. Hypersensitivity to the IMP, or components thereof, or significant drug or
other allergies
that, in the opinion of the investigator, contraindicates participation in the
study
14. Any other criteria which in the opinion of the Investigator causes the
subject not to qualify for the study