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Tests treatment safety and results for Mild Cognitive Impairment
Official title Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
ClinicalTrials.gov ID: NCT05591027
What this study is testing
What is Centella asiatica product?
Centella asiatica product is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mild cognitive impairment.
Also referred to as CAP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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...
- 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...
- Non-Alzheimer dementia such as vascular dementia, normal pressure hydrocephalus, or Parkinson's disease
- MMSE score of \ 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)
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.