Clinical trial NCT01001637: Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Keywords: curcumin
alzheimer's
longVida
dementia
Lead sponsor: Jaslok Hospital and Research Centre
Sponsor class: OTHER
Collaborators: name: Pharmanza Herbal Pvt Ltd
name: Verdure Sciences
name: University of California, Los Angeles
First posted: 2009-10-26
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams
timeFrame: 60 days
Secondary outcomes:
measure: To determine if curcumin formulation changes blood concentrations of amyloid-beta
timeFrame: 60 days
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Jaslok Hospital and research centre
state: Maharashtra
Study officials:
affiliation: Jaslok Hospital and Research Centre
name: Fali Poncha, DM neuro
role: STUDY_DIRECTOR
References: