Mild Cognitive ImpairmentNCT00595582
Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine
A study testing curcumin + bioperine in people with Mild Cognitive Impairment, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
This is an additional study to the primary Mild Cognitive Impairment (MCI) study (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment. This study has preliminary data that indicates objective analysis of PET brain image metabolic data is a sensitive marker for AD. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- curcumin + bioperine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Other neuropsychiatric diagnoses
- Major medical illness including potential secondary causes of cognitive decline.
- Disease, combination of disease, or presentation that, in the clinician's judgment, could introduce intolerable variance into the PET brain scan image
- Current substance or alcohol dependence or history of same, and no alcohol or substance abuse within the last eight weeks.
- Mild Alzheimer's Disease (AD) Inclusion criteria (patients):
- You must have a Mini Mental State Examination score of greater than 20.
Show all 43Show fewer
- You must have one or more of these signs and symptoms of mild AD all of which impair function and are worsening over time:
- Cognitive impairment manifested as memory problems
- problems with language
- difficulty carrying out motor activities
- difficulty naming things
- problems planning or organizing
- You must have at least 10 years of education, or a GED, or its equivalent.
- Positive for the ApoE4 genetic marker through blood test, or meet all other inclusion/exclusion criteria without exception.
- Age: 55-85.
- Normal or clinically unimportant physical exam
- Able to give informed consent/assent
- If you take medications that have an effect on the brain, they will be closely monitored. You will be PET-scanned only after a 24-hour washout of this medication(s), but this medication(s) will be restarted immediately after the scan.
- Mild Alzheimer's Disease (AD) Exclusion Criteria:
- Any problems related to the brain or mental disorders other than mild AD.
- You will get an MRI of your brain taken on the second visit, and a radiologist will read it. If there are any abnormal findings, you will be told, and these findings will be forwarded to your medical doctor. These findings may or may not result in your exclusion from the study.
- Any major medical illness
- Any disease, combination of disease, or presentation that, in the clinician's judgment, could introduce intolerable variance into the PET brain scan image.
- Current diagnosis of substance or alcohol dependence or a history of same and no alcohol or substance abuse within the last eight weeks.
- MCI Inclusion criteria (controls)
- Normal cognitive screening exam.
- Age: 55-85.
- At least 10 years of education or GED, or equivalent.
- Socioeconomic status, age, and sex matched.
- Able to give informed consent, or assent
- Centrally acting medications will be closely tracked, patients on any such medications will be PET-scanned only after a 24-hour washout, with meds restarted immediately after the scan.
- MCI Exclusion criteria (controls)
- First-degree relative with dementia or clinically relevant memory problems.
- Other Neuropsychiatric diagnoses
- Major medical illness
- Current or history of substance or alcohol dependence; no alcohol or substance abuse within the last eight weeks.
- MRI findings must be normal or unremarkable for the age of the patient.
- Disease, combination of disease, or presentation that, in the clinician's judgment, could introduce intolerable variance into the PET brain scan image
- Dropout criteria (all):
- Adverse events intolerable to the patient that prevent continued involvement in the study.
- New onset medical disorder of such significance as to prohibit further involvement.
- Initiation or recurrence of alcohol or substance abuse/dependence.
- Subject withdraws consent for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
About this study
This is an additional study to the primary Mild Cognitive Impairment (MCI) study (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment. This study has preliminary data that indicates objective analysis of PET brain image metabolic data is a sensitive marker for AD. The goal of this proposal is to determine the efficacy of curcumin in the treatment of MCI or mild Alzheimer's Disease (AD).
Read the detailed description
The specific aims of this study include:
- Determine if curcumin has an effect on neuropsychological scores in patients with MCI. Working Hypothesis: Patients with MCI that have evidence of objective memory impairment will have improvement on neuropsychological test scores.
- Determine if curcumin impacts the metabolic lesions found in patients who have MCI or may develop MCI. Working hypothesis: The metabolic lesions present that are consistent with the development of early AD will improve with curcumin treatment.
Patients diagnosed with MCI, patients who have metabolic lesions consistent with premorbid MCI, or mild AD and are currently enrolled in the primary MCI study (LSU#H04-049; NCT00243451) will be invited to participate in this clinical trial.
These subjects will be treated with 5.4 grams of curcumin per day (900 mg pills, two pills 3X/day with meals) with the inclusion of bioperine additive (formulated with the curcumin capsules) to improve bioavailability of the curcumin. Patients will be treated with curcumin/bioperine for 24 months concordant with the last two years of the three year longitudinal primary MCI study. Clinical endpoints will be change in neuropsychological scores, and size of metabolic lesions on the PET scan. Both of these measures will be recorded as part of the primary MCI study.
- Conditions
- Mild Cognitive Impairment
- Being tested
- curcumin + bioperine
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin + bioperineDietary supplement
Also called Life Extension Super Bio-Curcumin
Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | Curcumin + Bioperine Receives: Dietary Supplement: curcumin + bioperine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Scores in Patients With MCI or Mild AD.
Measured: within the next three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startMay 2005
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: For various reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport
- Investigators
- James C Patterson, MD, PhD, Principal investigator, LSU Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595582
- Sponsor's protocol ID
- LSU#H05-168
- Other IDs
- LSU#H05-168
- Status last verified
- May 2012
- First submitted
- 4 Jan 2008
- Last updated
- 28 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine
- ClinicalTrials.gov ID
- NCT00595582
- Acronym / sponsor ID
- LSU#H05-168
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For various reasons.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an additional study to the primary Mild Cognitive Impairment (MCI) study (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment. This study has preliminary data that indicates objective analysis of PET brain image metabolic data is a sensitive marker for AD. The goal of this proposal is to determine the efficacy of curcumin in the treatment of MCI or mild Alzheimer's Disease (AD).
Detailed description
The specific aims of this study include:
- Determine if curcumin has an effect on neuropsychological scores in patients with MCI. Working Hypothesis: Patients with MCI that have evidence of objective memory impairment will have improvement on neuropsychological test scores.
- Determine if curcumin impacts the metabolic lesions found in patients who have MCI or may develop MCI. Working hypothesis: The metabolic lesions present that are consistent with the development of early AD will improve with curcumin treatment.
Patients diagnosed with MCI, patients who have metabolic lesions consistent with premorbid MCI, or mild AD and are currently enrolled in the primary MCI study (LSU#H04-049; NCT00243451) will be invited to participate in this clinical trial.
These subjects will be treated with 5.4 grams of curcumin per day (900 mg pills, two pills 3X/day with meals) with the inclusion of bioperine additive (formulated with the curcumin capsules) to improve bioavailability of the curcumin. Patients will be treated with curcumin/bioperine for 24 months concordant with the last two years of the three year longitudinal primary MCI study. Clinical endpoints will be change in neuropsychological scores, and size of metabolic lesions on the PET scan. Both of these measures will be recorded as part of the primary MCI study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Dietary Supplement: curcumin + bioperineCurcumin + Bioperine |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (43 listed)
- Other neuropsychiatric diagnoses
- Major medical illness including potential secondary causes of cognitive decline.
- Disease, combination of disease, or presentation that, in the clinician's judgment, could introduce intolerable variance into the PET brain scan image
- Current substance or alcohol dependence or history of same, and no alcohol or substance abuse within the last eight weeks.
- You must have a Mini Mental State Examination score of greater than 20.
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 + bioperineAlso: Life Extension Super Bio-CurcuminSubjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study. | Dietary supplement | single arm |
Primary outcome
Neuropsychological Scores in Patients With MCI or Mild AD.
Time frame: within the next three years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James C Patterson, MD, PhD principal investigator
LSU Health Sciences Center
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 + bioperine in people with Mild Cognitive Impairment, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
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 0 inclusion and 43 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 May 2012. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 28 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neuropsychological Scores in Patients With MCI or Mild AD. (time frame: within the next three years). 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 May 2012.