Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT04645927
Eligibility Criteria:
Inclusion Criteria:
* Normal thyroid function (as determined by case history).
* Patients must have MCI or Minor Neurocognitive Disorder according to DSM-5 (see definition of DSM-5 under List of Abbreviations on Page 5).
* Ability to provide written informed consent.
* Age 60 to 84.
Exclusion Criteria:
* Any diagnosis of Alzheimer's Disease (AD) or Dementia by a physician.
* MoCA Cognitive Test Score outside 19-25 inclusive (determined in first Baseline Visit).
* DASS Test Score: Severe or Extremely Severe Score for any of the 3 measurements (Depression, Anxiety or Stress) (determined in the first Baseline Visit).
* Allergies to any of the components of the Test Product or Placebo (see Section 7.5).
* Lactose Intolerance or Allergy to any of the product components.
* Vitamin E, Vitamin B (any form), fish oil, omega pills or flaxseed products.
* Any significant neurological disease as determined during screening (case history). Examples include Parkinson's, Huntington's, brain tumor, seizure disorders, subdural hematoma, multiple sclerosis, history of head trauma including multiple head trauma with loss of consciousness.
* Diagnosis of diabetes mellitus as determined during screening (case history).
* Significant cerebrovascular or cardiovascular disease as determined during screening (case history).
* Psychotic features or history of schizophrenia as determined during screening (case history).
* Another major psychiatric disorder as described in DSM 5 within the past 2 years (see definition of DSM 5 as described under List of Abbreviations on Page 5).
* History of alcohol or substance abuse as determined during screening (case history).
* History of systemic cancer as determined during screening (case history).
* Sudden changes in bowel movements for more than 2 weeks, undiagnosed rectal bleeding, or failure to defecate following the use of a laxative.
* Presence of abdominal pain, nausea, vomiting or fever.
* Difficulty in swallowing (dysphagia).
* Blood Pressure (systolic \>180 and/or diastolic \>110). A stable dose of hypertension drugs for elevated blood pressure during the course of the study is not exclusionary.
* Non AD Medications: Use of centrally active beta-blockers, narcotics, methyldopa and clonidine within 4 weeks prior to screening.
* Use of anti-Parkinsonian medications (e.g. Sinemet, amantadine, bromocriptine, pergolide \& selegiline) within 2 months prior to screening.
* Use of neuroleptics or narcotic analgesics within 4 weeks prior to screening.
* Use of long-acting benzodiazepines or barbiturates within 4 weeks prior to screening.
* Use of short-acting anxiolytics or sedative hypnotics more frequently than 2 times per week within 4 weeks prior to screening (note: sedative agents should not be used within 72 hours of screening).
* Initiation or change in dose of an antidepressant lacking significant cholinergic side effects within the 4 weeks prior to screening (use of stable doses of antidepressants for at least 4 weeks prior to screening is acceptable).
* Use of systemic corticosteroids within 3 months prior to screening.
* Medications with significant cholinergic or anticholinergic side effects (e.g. pyridostigmine, tricyclic antidepressants, meclizine, and oxybutynin) within 4 weeks prior to screening.
* Use of anti-convulsants (e.g. Phenytoin, Phenobarbital, Carbamazepine) within 2 months prior to screening.
* Use of warfarin (Coumadin) within 4 weeks prior to screening.
* Any prior use of any FDA approved medications for the treatment of Alzheimer's disease (e.g. tacrine, donepezil, or other newly approved medications).
* Other: Subjects who, in the PI's opinion, will not comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
84 Years
Study:
NCT04645927
Study Brief:
Protocol Section:
NCT04645927