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18-Month Study of Memory Effects of Curcumin (Curcumin)

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ClinicalTrials.gov Identifier: NCT01383161
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : March 19, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles

Brief Summary:

This project is designed to study the effects of the dietary supplement curcumin on age-related cognitive impairment. In particular, the study seeks to determine the effects of curcumin on cognitive decline and the amount of abnormal amyloid protein in the brain. Genetic risk will also be studied as a potential predictor of cognitive decline.

Subjects will be randomly assigned to one of two treatment groups: either a placebo twice daily or the curcumin supplement (Theracurmin®, containing 90 mg of curcumin). The investigators expect that the volunteers receiving the curcumin supplement will show less evidence of decline after 18 months than those receiving the placebo. The investigators predict that cognitive decline and treatment response will vary according to genetic risk for Alzheimer's.

The investigators will study subjects with memory complaints aged 50-90 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints. Subsequently, subjects will undergo an -(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile (FDDNP) PET scan and a baseline neuropsychological assessment to confirm a diagnosis of MCI or normal aging. Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo). Some of the initial subjects will be asked to return every three months for regular MRIs. Every 6 months, subjects will also receive neuropsychological assessments. At the conclusion of the study, subjects will be asked to complete a final neuropsychological assessment, MRI scan, PET scan and blood draw. Additional blood will be drawn at baseline and at 18 months and frozen to assess inflammatory markers if cognitive outcomes are positive.

FDDNP-PET scans will be used to measure the amount of abnormal amyloid plaque- and tau tangle-proteins in the brain; the MRIs will be used to monitor supplement side effects and measure brain structure; the neuropsychological assessments will monitor rates of cognitive decline; the blood draws will be used to determine genetic risk and to test levels of inflammatory markers.


Condition or disease Intervention/treatment Phase
Age-associated Cognitive Impairment Mild Cognitive Impairment (MCI) Drug: Curcumin Other: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 18-Month Double-Blind, Placebo-Controlled Study of Curcumin
Actual Study Start Date : March 2012
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: Curcumin
Theracurmin (180mg/day)
Drug: Curcumin
Six Theracurmin capsules (containing 30 mg of curcumin each) per day for 18 months.
Other Name: Theracurmin CR-031P™ (Dietary Supplement)

Placebo Comparator: Placebo
Sugar Pill
Other: Placebo
Six capsules per day for 18 months.
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Recall [ Time Frame: Baseline and 18 Months ]
    The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Recall measures standard scoring of designs for accuracy and correct placement across the three trials. Scores across the three trials are summed and range from 0 to 36, with higher scores indicating better learning. There are 6 equivalent alternate forms.

  2. Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Delay [ Time Frame: Baseline and 18 Months ]
    The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Delayed recall measures standard scoring of designs for accuracy and correct placement after delay period. Scores range from 0 to 12 and reflect recent, long-term learning, with higher scores indicating better learning. There are 6 equivalent alternate forms.

  3. Change From Baseline on Buschke Selective Reminding Task, Consistent Long-Term Retrieval [ Time Frame: Baseline and 18 Months ]
    Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.

  4. Change From Baseline on Buschke Selective Reminding Task, Total Score [ Time Frame: Baseline and 18 Months ]
    Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Total Recall score is the sum of words recalled over the 12 trials, which reflects immediate recall (short-term memory) for new information. Scores range from 0 to 144, with higher scores indicating better learning.


Secondary Outcome Measures :
  1. Change From Baseline to 18 Months on Trail Making Test, Part A [ Time Frame: Baseline and 18 Months ]
    Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a circle from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Respondents were allotted as much time as necessary to complete the task. Higher scores indicate greater impairment.

  2. Change From Baseline to 18 Months on Beck Depression Inventory (BDI) [ Time Frame: Baseline and 18 Months ]
    Beck Depression Inventory is a self-reported questionnaire consisting of 21 items that assess for core depressive symptoms, including sadness, sleep, suicidality, and anhedonia. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (no depressive symptoms) to 84 (extreme depression), with higher scores indicating more significant depression.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Agreement to participate in the 18-month double-blind, placebo-controlled clinical trial of curcumin.
  2. Diagnostic criteria for mild cognitive impairment (MCI) or any age related memory decline according to standard criteria (Petersen et al, 2001; Crook et al, 1986).
  3. Age 50 to 90 years.
  4. No significant cerebrovascular disease: modified Ischemic Score of < 4 (Rosen et al, 1980).
  5. Adequate visual and auditory acuity to allow neuropsychological testing.
  6. Screening laboratory tests and EKG without significant abnormalities that might interfere with the study.

Exclusion Criteria

  1. Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal) (McKhann et al, 1984).
  2. Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of stroke, TIA, carotid bruits, or lacunes on MRI scans will be excluded.
  3. Inability to undergo MRI.
  4. Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale (Fahn et al, 1987).
  5. History of myocardial infarction within the previous year, or unstable cardiac disease.
  6. Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100).
  7. History of significant liver disease, clinically-significant pulmonary disease, diabetes, or cancer.
  8. Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
  9. Current diagnosis or history of alcoholism or substance addiction.
  10. Regular use of any medication that may affect cognitive functioning including: centrally active beta-blockers, narcotics, Clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or Warfarin. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
  11. Use of more than one multivitamin per day. Vitamins other than the standard multivitamin supplement will not be allowed.
  12. Use of medications known to affect FDDNP-PET binding (e.g., ibuprofen, naproxen).
  13. Use of more than one daily baby aspirin (81mg) and/or use of any medication containing curcumin.
  14. Use of cognitive enhancing supplements (e.g. Ginkgo biloba).
  15. Use of any investigational drugs within the previous month or longer, depending on drug half-life.
  16. Pregnancy.
  17. HIV infection.
  18. Evidence of vasogenic edema; specifically, evidence of more than 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite") or a single area of superficial siderosis), or evidence of a prior macrohemorrhage at screening or baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383161


Locations
United States, California
UCLA Longevity Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Gary W Small, MD UCLA Longevity Center
  Study Documents (Full-Text)

Documents provided by Gary Small, MD, University of California, Los Angeles:

Additional Information:
Publications:
[No authors listed] Consensus report of the Working Group on:

Responsible Party: Gary Small, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01383161     History of Changes
Other Study ID Numbers: 11-001740
IND 112714 ( Other Identifier: FDA )
First Posted: June 28, 2011    Key Record Dates
Results First Posted: March 19, 2018
Last Update Posted: October 17, 2018
Last Verified: October 2018

Keywords provided by Gary Small, MD, University of California, Los Angeles:
Curcumin
Turmeric
Memory
Cognitive Impairment
Brain Imaging
Supplement

Additional relevant MeSH terms:
Curcumin
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action