Cognitive Effects of Bioavailable Curcumin

Phase 2WithdrawnNCT07251985

University of California, Los Angeles

Overview

An estimated 50% of older adults complain of memory changes that worsen as they age. Although numerous commercially available dietary supplements claim cognitive benefits, relatively few well-designed, longitudinal, placebo-controlled studies have rigorously evaluated their effects on cognitive performance. In a previous double-blind, randomized, placebo-controlled, 18-month clinical trial in middle-aged and older non-demented adults, the investigators found that a bioavailable form of curcumin taken orally twice a day showed greater gains on specific measures of memory and attention relative to placebo. Although the investigators found significant between-group curcumin/placebo differences with moderate effect sizes, the sample size (n=40) was small. The present adequately powered, randomized, double-blind, placebo-controlled study will evaluate the effect of daily consumption of bioavailable curcumin on measurable changes in cognitive performance in non-demented middle-aged and older adults.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Conditions

Memory Cognitive Function Decline

Interventions

CurcuminDIETARY_SUPPLEMENT

Theracurmin Super TS-P1 capsules containing 75 mg in total of curcumin will be administered orally (swallowed with water) twice a day (during breakfast and dinner) for 12 months

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. Presence of age-related memory complaints; 2. Male or female aged 50 to 85 years of age at Visit 1. 3. performance on MoCA test of \>= 18 (Milani et al, 2018) 4. Ability to perform normal daily activities independently (which excludes a diagnosis of dementia). 5. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. 6. Agreement to participate in the entire study, which could last either 6 or 12 months depending on results of the interim analysis. 7. Adequate visual and auditory acuity for cognitive testing. 8. Screening laboratory tests that do not show significant medical problems that might interfere with study participation or impact cognitive test results. 9. Psychotropic medication, if used, should be stable for at least 2 weeks prior to randomization. 10. Agreement to avoid taking any curcumin, turmeric supplements or cognitive enhancing medicines or supplements during the course of the study. Exclusion Criteria 1. Allergy to curcumin 2. Presence of a condition or abnormality that in the opinion of the site Principal Investigator would compromise the safety of the patient or the quality of the data. 3. Significant cerebrovascular disease or Alzheimer disease or any other dementia. 4. Neurological or physical illnesses that can produce cognitive deterioration. 5. History of myocardial infarction within the previous year or unstable cardiac disease. 6. Uncontrolled hypertension (systolic BP \> 170 or diastolic BP \> 100); significant liver or pulmonary disease, or cancer; 7. Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria with a change in medication or clinical symptoms with the last 3 months prior to screening (APA, 2000). 8. History of alcoholism or substance addiction in the last 15 years. 9. Current treatment for seizure disorder; 10. Abnormal laboratory values with clinical significance in the opinion of the site Principal Investigator. 11. Current unstable medical illness including delirium, worsening congestive heart failure, unstable angina, recent myocardial infarctions, acute infectious disease, severe renal or hepatic failure, severe respiratory disease, metastatic cancer, or other conditions that, in the Principal Investigator's opinion, could interfere with the analysis of safety and efficacy in this study. 12. A 2-week washout is required prior to baseline for any of the following: curcumin or turmeric supplements, any anti-inflammatory medication other than occasional use (e.g., once per week). 13. The subject may not be an immediate family member (e.g., spouse, parent, child, sibling) of personnel directly affiliated with this study, the study site or study funding agency.

Outcomes

Primary Outcomes

Memory

The primary endpoint will be a memory domain score calculated from the Consistent Long Term Recall score of the Buschke Selective Reminding Test (SRT)

Time frame: 12 months

Memory

Delayed Recall score of the Brief Visual Memory Test-Revised (BVMT-R).

Time frame: 12 months

Secondary Outcomes

Cognitive function test

NIH TOOLBOX computerized set of cognitive tests

Time frame: 12 months

PROMIS Cognitive Function

Short Form 20a is a standardized questionnaire designed to assess an individual's self-reported cognitive abilities and problems over the past 7 days. It includes 20 items and is part of the Patient-Reported Outcomes Measure. The instrument produces a T-score standardized to the PROMIS metric. T-scores typically range from 20 to 80, with a population mean of 50 and standard deviation of 10.

Time frame: 12 months

Self-reported depression symptoms

Measured by Beck Depression Inventory (BDI). A 21-item self-report questionnaire assessing the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression (i.e., a worse outcome).

Time frame: 12 months

Blood levels of curcumin

(to ensure adherence to protocol)

Time frame: 12 months

Inflammation and neurodegenerative markers

such as, TNF-α, C-reactive protein

Time frame: 12 months

Data from ClinicalTrials.gov

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