Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01001637

Enrollment

Registered

2009-10-26

Start date

2009-10-31

Completion date

2010-11-30

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

curcumin, alzheimer's, longVida, dementia

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTCurcumin Formulation

2000mg or 3000mg daily BID

DIETARY_SUPPLEMENTPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams	60 days

Secondary

Measure	Time frame
To determine if curcumin formulation changes blood concentrations of amyloid-beta	60 days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026