Alzheimer DiseaseNCT01001637
Efficacy and Safety of Curcumin Formulation in Alzheimer's Disease
A study testing Curcumin Formulation in people with Alzheimer Disease, run by Jaslok Hospital and Research Centre at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Curcumin Formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Alzheimer Disease
- Being tested
- Curcumin Formulation, Placebo
- Keywords
- curcumin, alzheimer's, longVida, dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin FormulationDietary supplement
Also called Longvida
2000mg or 3000mg daily BID
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| curcumin | Active comparator | Not described Receives: Dietary Supplement: Curcumin Formulation |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams
Measured: 60 days
Secondary outcomes (1)
To determine if curcumin formulation changes blood concentrations of amyloid-beta
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionNov 2010
Why it stopped: lack of support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaslok Hospital and Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmanza Herbal Pvt Ltd, Verdure Sciences, University of California, Los Angeles
- Responsible party
- Principal investigator, Dr Paresh Doshi, Jaslok Hospital and Research Centre
- Investigators
- Fali Poncha, DM neuro, Study director, Jaslok Hospital and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001637
- Sponsor's protocol ID
- Longvida
- Other IDs
- 919820711140
- Status last verified
- Sep 2023
- First submitted
- 15 Oct 2009
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01001637
- Acronym / sponsor ID
- Longvida
- Conditions
- Alzheimer Disease
- Keywords
- curcumin, alzheimer's, longVida, dementia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of support
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jaslok Hospital and Research CentreUniversity, hospital or other
- Collaborators
- Pharmanza Herbal Pvt Ltd, Verdure Sciences, University of California, Los Angeles
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curcumin | Active comparator | Dietary Supplement: Curcumin Formulation |
| placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin FormulationAlso: Longvida2000mg or 3000mg daily BID | Dietary supplement | curcumin |
| PlaceboPlacebo | Dietary supplement | placebo |
Primary outcome
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams
Time frame: 60 days
1 secondary outcome
To determine if curcumin formulation changes blood concentrations of amyloid-beta
Time frame: 60 days
Results and safety
The study was stopped early (reason given: lack of support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fali Poncha, DM neuro study director
Jaslok Hospital and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin Formulation in people with Alzheimer Disease, run by Jaslok Hospital and Research Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.