Evaluating the effects of Centella asiatica on cognitive impairment

Safety and Target Engagement of Centella Asiatica in Cognitive Impairment

This study is testing if a water extract from the Centella asiatica plant can help improve brain health in older adults with mild cognitive impairment or Alzheimer's disease.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: Oregon Health and Science University (other)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT05591027 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial investigates the safety and biological effects of a Centella asiatica water extract product in older adults aged 60-85 with mild cognitive impairment or Alzheimer's disease. Participants will receive either the Centella asiatica extract or a placebo daily for six weeks, with assessments conducted before and after the intervention. The study aims to measure biological signatures related to brain health, including neuronal viability and oxidative stress, while ensuring participant safety and tolerability.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 60-85 with mild cognitive impairment or mild Alzheimer's disease who meet specific health criteria.

Not a fit: Patients with significant depression symptoms or those who are allergic to Centella asiatica may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for improving cognitive function in older adults with mild cognitive impairment or Alzheimer's disease.

How similar studies have performed: While there is limited data on Centella asiatica specifically, similar studies exploring botanical extracts for cognitive impairment have shown promise, indicating potential for success.

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)

Where this trial is running

Portland, Oregon

• Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Amala Soumyanath, Ph.D — Oregon Health and Science University
• Study coordinator: Amala Soumyanath, PhD

Conditions: Mild Cognitive Impairment, Alzheimer's Disease