Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cerecin
Age
66–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Dementia status of mild to moderate
CT or MRI scan within 18 months prior to screening compatible with a diagnosis of probable Alzheimer's disease
Score on the Wechsler Memory Scale - Logical Memory II recall below a pre-determined cut-off, adjusted for education level
Confirmed apolipoprotein E genotype prior to randomization
Prior and current use of medication that corresponds with protocol requirements
Stable medical condition, with the exception of dementia, for at least 3 consecutive months prior to screening
No active suicidal thoughts within 6 months of screening, no active history of suicide attempt in the previous 2 years, no more than 1 lifetime suicide attempt, no serious suicidal risk
Able to comply with protocol testing and procedures for the duration of the study
Has a permanent caregiver (caregiver is not expected to change during the course of the study) who is willing to attend all visits, oversee the participant's compliance with protocol procedures and study medication administration, and report on the participant's status
Resides in the community (includes assisted living facilities, but excludes long-term care nursing facilities)
Both participant and caregiver have the ability to read and write in English or Spanish and have hearing, vision and physical abilities adequate to perform the assessments (corrective aids allowed)
Participant and caregiver have provided full written informed consent prior to the performance of any protocol-specified procedure. If participant is unable to provide informed consent due to cognitive status, provision of informed consent by cognitively intact legally acceptable representative (where this is in accordance with local laws, regulations and ethics committee policy)
Participant is able to ingest oral medication
You may not be if
Current use, or use within 3 months of baseline, of medium-chain triglyceride-containing products
Use of any other investigational agent within 60 days prior to screening
Known allergy or hypersensitivity to milk or soy products
In the opinion of the investigator, presence or history of advanced, severe, progressive or unstable disease of any type that could interfere with protocol assessments or put the participant at particular risk
Any medical or neurological condition other than Alzheimer's disease that could explain the patient's dementia
History or clinical laboratory evidence of moderate congestive heart failure
Clinically significant ECG abnormalities at screening
History of new cardiovascular events within 6 months prior to baseline
History of or current psychiatric illness
Major depression as determined by Cornell Scale for Depression in Dementia
Drop of 20 mm Hg systolic blood pressure or greater upon standing upright from a seated position within 3 minutes at screening
Clinically significant anemia at screening
Clinically significant renal disease or insufficiency at screening
Laboratory values for liver function tests \> 2.5 times the upper limit of normal at screening or history of severe liver disease
Fasting triglycerides \> 2.5 times the upper limit of normal at screening
Clinically significant B12 deficiency within 12 month prior to screening
Inflammatory bowel disease or peptic ulcer disease.
Participants with current or a history of (within the last 5 years) complicated reflux disease or severe GERD that is not well-controlled by medication.
Irritable bowel syndrome, diverticular disease (e.g., diverticulosis or diverticulitis), or chronic gastritis (exclusionary if there has been a diagnosis or an acute event within 5 years prior to Screening.)
Has donated ≥ 2 units of blood within the 2 months prior to screening
History of alcohol or drug abuse within 6 months prior to screening, or positive urine drug test at screening
Participant or caregiver is an immediate family member or employee of the clinical site, sponsor or sponsor's agents
An alternative cause for dementia other than Alzheimer's disease as determined by a required CT or MRI scan within 18 months prior to screening
History of neoplasm or malignancies within 5 years prior to screening, except for basal cell or squamous cell carcinoma of the skin
Clinically significant hypothyroidism as determined thyroid function testing at screening
Participant has scheduled or expected hospitalization and/or surgery during the course of the study
