Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

Study Overview
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Brief Summary
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Curcumin is shown to impact several different pathways of neuroprotection, however clinical trials have not shown positive results, due to the poor bioavailability of curcumin. This study is designed to determine efficacy and safety of high-bioavailability curcumin formulation (Longvida) in subjects with Alzheimer's disease.

Detailed Description
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Curcumin is a polyphenolic molecule that comprises approximately 3-5% of turmeric (Curcuma longa) root, giving the spice its characteristic yellow color. Because of its anti-inflammatory, anti-amyloid, and antioxidant properties, curcumin has shown positive effects in animal models of Alzheimer's disease (AD). However, a six month human study was conducted with unformulated curcumin showing insignificant trends, due to limited bioavailability and brain permeability of unformulated curcumin. In animal models of AD, oral dosing of solid-lipid curcumin particle (SLCP or Longvida) significantly reduced memory deficit and impacted biomarkers better than unformulated curcumin. This study is to determine the potential efficacy and safety of highly absorbed SLCP curcumin in subjects with AD.

Official Title
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Phase II Study of Curcumin Formulation (Longvida) or Placebo on Plasma Biomarkers and Mental State in Moderate to Severe Alzheimer's Disease or Normal Cognition

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: Curcumin Formulation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female age ≥ 50. Diagnosed with probable AD using NINDS-ADRDA research criteria. MMSE score ≥5 and ≤20. No history of significant psychiatric or non-AD neurological disease. An available caregiver to monitor and administer medication and to accompany the subject to every clinical visit. On stable doses of concomitant medications for at least one month prior to starting study medication. Exclusion Criteria: Current or recent major psychiatric illness that meets DSM-IV criteria (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 per DSM-IV criteria. Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: curcumin<br> | Dietary Supplement: Curcumin Formulation<br>* 2000mg or 3000mg daily BID<br>* Other names: Longvida;|
| Placebo Comparator: placebo<br> | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if curcumin formulation changes blood concentrations of amyloid-beta |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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curcumin, alzheimer's, longVida, dementia