Safety and Target Engagement of Centella Asiatica in Cognitive Impairment

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is focused on determining whether biological signatures of target engagement by a Centella asiatica water extract product administered orally for 6 weeks can be measured in comparison to placebo. This study will also assess the safety and tolerability of the Centella asiatica water extract product.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Alzheimer's Association

Criteria

Inclusion Criteria:

• Age 65-85, 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 magnetic resonance imaging scans

• Meet the National Institute of Aging - Alzheimer's Association core clinical criteria for mild cognitive impairment or probable Alzheimer's disease 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 Alzheimer's disease 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 Diagnostic and Statistical Manual of Mental Disorders (DSM)-Five(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 diabetes mellitus, 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

• Mini Mental State Examination (MMSE) score of < 20 or > 28

• Unwilling to maintain stable dosage of Alzheimer's disease 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 (metal implants, pacemakers, claustrophobia)