Alzheimer disease dementia
Conditions
Interventions
If the screening has been successfully passed, the subject will be randomized
after the placebo run-in phase on Day 1 to one of the possible treatment arms.
- Group 1: Active dose oral suspension twi
Sponsors
ReMYND
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Incidence of treatment-emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| NA Exploratory endpoints are listed in protocol in section 3.0 | — |
Countries
Netherlands
Outcome results
None listed