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TerminatedNCT01001637Updated Sep 28, 2023

Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease

An interventional study of Curcumin Formulation and Placebo in Alzheimer Disease, sponsored by Jaslok Hospital and Research Centre. Terminated at 1 site in India. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Jaslok Hospital and Research Centre · Not applicable, Interventional, and Treatment

Why this study was terminated
lack of support
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alzheimer Disease

Keywords

  • curcumin
  • alzheimer's
  • longVida
  • dementia
03

In context

Alzheimer Disease

3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 26 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Jaslok Hospital and Research Centre is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    curcumin

    Dietary Supplement: Curcumin Formulation

  • Placebo comparator
    placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementCurcumin Formulation

    2000mg or 3000mg daily BID

    Also known as: Longvida

  • Dietary supplementPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams

    Time frame: 60 days

Secondary outcomes

  1. To determine if curcumin formulation changes blood concentrations of amyloid-beta

    Time frame: 60 days

07

Study locations

1 site
  • Jaslok Hospital and research centre
    Mumbai, Maharashtra 400026, India
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Jun 2010 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2009
First posted
Oct 26, 2009
Start
Oct 2009
Primary completionActual
Jun 2010
CompletionActual
Nov 2010
Last update
Sep 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01001637
Lead sponsor
Jaslok Hospital and Research Centre
Collaborators
Pharmanza Herbal Pvt Ltd, Verdure Sciences, University of California, Los Angeles
Responsible party
Dr Paresh Doshi (administrator, Jaslok Hospital and Research Centre) — Principal investigator
First posted
Oct 26, 2009
Start date
Oct 2009
Primary completion
Jun 2010
Completion
Nov 2010
Last update
Sep 28, 2023

Study contacts

Fali Poncha, DM neuro
study director · Jaslok Hospital and Research Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Curcumin

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