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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT05591027
Eligibility Criteria:
Inclusion criteria:
* Age 60-85, male and female
* Sufficient English language skills to complete all tests
* Sufficient vision and hearing to complete all tests
* No known allergies to Centella asiatica
* Absence of significant depression symptoms (Geriatric Depression Scale-15 score of \< 5).
* Total score of \<2 on the suicidal ideation subscale (measures 3, 7, 11, 12 and 14) of the Geriatric Depression Scale.
* Body Mass Index (BMI) greater than 17 and less than 35 at screening
* General health status that will not interfere with the ability to complete the study
* Willingness to discontinue all botanical dietary supplements for one week prior to and during the study.
* Willingness to undertake multiple MRI scans
* Meet the National Institute of Aging - Alzheimer's Association core clinical criteria for MCI or probable AD dementia with a Clinical Dementia Rating score of 0.5-1 and Mini Mental State Examination score of 20-28 at screening and baseline
* Participants who report a history of participative memory decline with gradual onset and slow progression over the last one year before screening MUST be corroborated by an informant.
* Participants on acetylcholinesterase inhibitor or memantine therapy for AD must be on a stable dose for at least 12 weeks prior to baseline visit.
* Participants must have an identified caregiver/study partner that can accompany participant to all study visits.
Exclusion criteria:
* Current smoking, alcohol, or substance abuse according to DSM-V criteria
* Women who are pregnant, planning to become pregnant, or breastfeeding
* Men who are actively trying to conceive a child or planning to within three months of study completion
* Severe aversion to venipuncture
* Abnormal labs indicating asymptomatic and untreated urinary tract infection
* Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade \< 3) and non-metastatic skin cancers
* Comorbid conditions such as type I diabetes mellitus, poorly controlled type II diabetes mellitus (HbA1c \> 7%), kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease
* Significant disease of the Central Nervous System (CNS) such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
* Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria
* Medications: anti-epileptics, sedatives, amitriptyline, anticoagulants (e.g., warfarin), investigational drugs used within five half-lives of baseline visit, systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, narcotic analgesics, nicotine (tobacco, patches, gum, lozenges, etc.), Cannabis sativa (herb or edibles), beta blockers and anti-depressant medications that have not been at stable dosage for two months (including SSRIs, SNRIs)
* Non-Alzheimer dementia such as vascular dementia, normal pressure hydrocephalus, or Parkinson's disease
* MMSE score of \< 20 or \> 28
* Unwilling to maintain stable dosage of AD medications throughout study duration
* Unwilling to maintain stable dosage of intervention throughout the course of the study
* Contraindications to Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) scans (some metal implants, pacemakers, claustrophobia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT05591027
Study Brief:
Protocol Section:
NCT05591027