Curcumin in Patients With Mild to Moderate Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00099710 |
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Recruitment Status :
Completed
First Posted : December 20, 2004
Last Update Posted : December 3, 2009
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Dietary Supplement: Curcumin C3 Complex | Phase 2 |
Curcumin, a yellow substance found in the spice Turmeric, has antioxidant, non-steroidal anti-inflammatory (NSAID), and cholesterol-lowering properties, all of which make it a good candidate in the prevention and treatment of AD. The study will examine the safety and tolerability of 2 different doses of curcumin C3 complex. Blood and cerebrospinal fluid (CSF) tests will be used to examine how the curcumin is absorbed in the body, and whether it has an effect on inflammation, oxidative damage, and cholesterol levels. Participants will also be tested to determine the potential effect of curcumin on cognition, behavior, and daily function in patients with mild to moderate AD.
Participants will be randomly assigned to receive one of two doses of curcumin, or a placebo, for the initial 6 months of the trial. For the final 6 months, those receiving a placebo will be switched to one of the two doses of the drug. The 33 participants will make 7 visits to the study site over a 12-month period. These visits may include a physical and neurological examination, routine laboratory tests, lumbar puncture, and neuropsychological (mood and memory) evaluations.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 33 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of Two Doses of Curcumin C3 Complex Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease |
| Study Start Date : | July 2003 |
| Actual Primary Completion Date : | December 2007 |
| Actual Study Completion Date : | December 2007 |
- Side effect checklist
- Oxidative damage
- Inflammation/gliosis
- A-beta levels
- Tau levels
- Total plasma cholesterol, LDL and HDL; ApoE
- Plasma curcumin and metabolites
- Cognitive and behavioral measures
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female at least 50 years old
- Diagnosis of probable AD
- No history of significant psychiatric or non-AD neurological disease
- Proficient in English to be able to perform cognitive testing
- Caregiver available to monitor and administer medication and to accompany patient to every clinical visit
- On stable doses of cholinesterase inhibitors and memantine (Alzheimer's medications) for 3 months prior to enrollment
- On stable doses of all other allowed medications for at least one month prior to starting the study medication
Exclusion Criteria:
- Current or recent major psychiatric illness (i.e. bipolar disorder, schizophrenia)
- Significant, uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure)
- Recent history of gastrointestinal bleeding or ulceration
- Alcoholism or substance abuse within the past year
- Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein)
- NSAIDs (e.g. ibuprofen, naproxen, etc.) taken on a regular basis (more than 3 times per week)
- Aspirin at doses more than 325 mg per day
- Coumadin, heparin, other anticoagulants
- Antioxidants or other supplements including gingko biloba, coenzyme Q10, alpha-lipoic acid
- Vitamin E at doses more than 2,000 IU per day
- Vitamin C at doses more than 500 mg per day
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): NCT00099710
| United States, California | |
| UCLA Medical Center | |
| Westwood, California, United States | |
| Study Director: | John Ringman, MD | University of California, Los Angeles |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00099710 |
| Other Study ID Numbers: |
IA0065 |
| First Posted: | December 20, 2004 Key Record Dates |
| Last Update Posted: | December 3, 2009 |
| Last Verified: | December 2009 |
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Curcumin Turmeric Curry NSAID |
anti-inflammatory Cholesterol anti-oxidant |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Curcumin 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 |