Alzheimer's DiseasePhase 1/2NCT00164749
A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
A Phase 1/2 study testing Curcumin and ginkgo extract in people with Alzheimer's Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Curcumin and ginkgo extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2004to Jul 2006
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnic Chinese living in Hong Kong
- Progressive decline in memory and cognitive function for at least 6 months
- NINCDS-ADRDA diagnosis of possible or probable AD
- Mild to severe dementia with Cantonese version of MMSE scores between 0 and 28
- Informed consent from patient and/or caregiver
- Both elderly home residents and outpatients are eligible
- Patients may take any medication
Who cannot join
- Anticoagulant or antiplatelet treatment or bleeding risk factors
- Currently smoking
- Other severe, end-stage illness
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.
Read the detailed description
A double-blind, randomized, clinical trial of 30 subjects will be carried out to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression. Curcumin is a polyphenolic molecule extracted from turmeric and is widely and safely used as a yellow food coloring. Because of its strong anti-inflammatory activity, curcumin was tested in animal models of AD, where it significantly reduced levels of brain amyloid, oxidized proteins, and isoprostanes, and prevented cognitive deficits. AD patients will receive placebo, 1 g, or 4 g of curcumin daily for six months. All patients will also receive 120 mg ginkgo leaf extract daily. At 0, 1, 3, and 6 months of the study, a cognitive test will be performed, and blood samples will be analyzed for levels of isoprostane, amyloid beta protein, metals, and cholesterol. Curcumin and its metabolites will be measured in blood at 1 month. The primary objective for this first human study of curcumin in AD is to examine safety and procedures for a possible larger trial testing curcumin against AD. The secondary objective is to determine whether curcumin affects biochemical measures, and, if so, which dose is most effective. The tertiary objective is to determine whether curcumin slows cognitive decline in AD. This study may lead to inexpensive treatment that delays progression of AD.
- Conditions
- Alzheimer's Disease
- Being tested
- Placebo and ginkgo extract, Curcumin and ginkgo extract
- Keywords
- dementia, cognition, memory, neurodegenerative disease, brain
- Medical subject headings
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo and ginkgo extractDrug
Placebo once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
Curcumin and ginkgo extractDrug
1 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
Curcumin and ginkgo extractDrug
4 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Color-matched placebo Receives: Drug: Placebo and ginkgo extract |
| 1 gram | Experimental | 1 g/day curcumin Receives: Drug: Curcumin and ginkgo extract |
| 4 gram | Experimental | 4 g/day curcumin Receives: Drug: Curcumin and ginkgo extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isoprostane level in plasma
Measured: 1 and 6 months
Change in A-beta level in serum
Measured: 1 and 6 months
Secondary outcomes (4)
Change in cognitive function (MMSE score)
Measured: 6 months
Change in cholesterol and triglycerides in serum
Measured: 1 and 6 months
Change in metals in serum
Measured: 1 month
Level of curcumin in plasma vs. dose
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Bupa Chile, Kwong Wah Hospital
- Investigators
- Larry Baum, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164749
- Sponsor's protocol ID
- CRE-2003.090-T
- Status last verified
- Apr 2008
- First submitted
- 9 Sep 2005
- Last updated
- 30 Apr 2008
- Results posted
- No
Publications
Baum L, Lam CW, Cheung SK, Kwok T, Lui V, Tsoh J, Lam L, Leung V, Hui E, Ng C, Woo J, Chiu HF, Goggins WB, Zee BC, Cheng KF, Fong CY, Wong A, Mok H, Chow MS, Ho PC, Ip SP, Ho CS, Yu XW, Lai CY, Chan MH, Szeto S, Chan IH, Mok V. Six-month randomized, placebo-controlled, double-blind, pilot clinical trial of curcumin in patients with Alzheimer disease. J Clin Psychopharmacol. 2008 Feb;28(1):110-3. doi: 10.1097/jcp.0b013e318160862c. No abstract available.
PubMed 18204357Baum L, Cheung SK, Mok VC, Lam LC, Leung VP, Hui E, Ng CC, Chow M, Ho PC, Lam S, Woo J, Chiu HF, Goggins W, Zee B, Wong A, Mok H, Cheng WK, Fong C, Lee JS, Chan MH, Szeto SS, Lui VW, Tsoh J, Kwok TC, Chan IH, Lam CW. Curcumin effects on blood lipid profile in a 6-month human study. Pharmacol Res. 2007 Dec;56(6):509-14. doi: 10.1016/j.phrs.2007.09.013. Epub 2007 Sep 18.
PubMed 17951067
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00164749
- Acronym / sponsor ID
- CRE-2003.090-T
- Conditions
- Alzheimer's Disease
- Keywords
- dementia, cognition, memory, neurodegenerative disease, brain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Bupa Chile, Kwong Wah Hospital
- Study start
- Oct 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 14 Sep 2005 (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.
The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.
Detailed description
A double-blind, randomized, clinical trial of 30 subjects will be carried out to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression. Curcumin is a polyphenolic molecule extracted from turmeric and is widely and safely used as a yellow food coloring. Because of its strong anti-inflammatory activity, curcumin was tested in animal models of AD, where it significantly reduced levels of brain amyloid, oxidized proteins, and isoprostanes, and prevented cognitive deficits. AD patients will receive placebo, 1 g, or 4 g of curcumin daily for six months. All patients will also receive 120 mg ginkgo leaf extract daily. At 0, 1, 3, and 6 months of the study, a cognitive test will be performed, and blood samples will be analyzed for levels of isoprostane, amyloid beta protein, metals, and cholesterol. Curcumin and its metabolites will be measured in blood at 1 month. The primary objective for this first human study of curcumin in AD is to examine safety and procedures for a possible larger trial testing curcumin against AD. The secondary objective is to determine whether curcumin affects biochemical measures, and, if so, which dose is most effective. The tertiary objective is to determine whether curcumin slows cognitive decline in AD. This study may lead to inexpensive treatment that delays progression of AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo and ginkgo extractColor-matched placebo |
| 1 gram | Experimental | Drug: Curcumin and ginkgo extract1 g/day curcumin |
| 4 gram | Experimental | Drug: Curcumin and ginkgo extract4 g/day curcumin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ethnic Chinese living in Hong Kong
- Progressive decline in memory and cognitive function for at least 6 months
- NINCDS-ADRDA diagnosis of possible or probable AD
- Mild to severe dementia with Cantonese version of MMSE scores between 0 and 28
- Informed consent from patient and/or caregiver
Key exclusion criteria (3 listed)
- Anticoagulant or antiplatelet treatment or bleeding risk factors
- Currently smoking
- Other severe, end-stage illness
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 |
|---|---|---|
| Placebo and ginkgo extractPlacebo once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract. | Drug | Placebo |
| Curcumin and ginkgo extract1 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract. | Drug | 1 gram |
| Curcumin and ginkgo extract4 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract. | Drug | 4 gram |
Primary outcome
Change in isoprostane level in plasma
Time frame: 1 and 6 months
Change in A-beta level in serum
Time frame: 1 and 6 months
4 secondary outcomes
Change in cognitive function (MMSE score)
Time frame: 6 months
Change in cholesterol and triglycerides in serum
Time frame: 1 and 6 months
Change in metals in serum
Time frame: 1 month
Level of curcumin in plasma vs. dose
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2008.
- Results publication: PubMed 18204357Baum L, Lam CW, Cheung SK, Kwok T, Lui V, Tsoh J, Lam L, Leung V, Hui E, Ng C, Woo J, Chiu HF, Goggins WB, Zee BC, Cheng KF, Fong CY, Wong A, Mok H, Chow MS, Ho PC, Ip SP, Ho CS, Yu XW, Lai CY, Chan MH, Szeto S, Chan IH, Mok V. Six-month randomized, placebo-controlled, double-blind, pilot clinical trial of curcumin in patients with Alzheimer disease. J Clin Psychopharmacol. 2008 Feb;28(1):110-3. doi: 10.1097/jcp.0b013e318160862c. No abstract available.
- Results publication: PubMed 17951067Baum L, Cheung SK, Mok VC, Lam LC, Leung VP, Hui E, Ng CC, Chow M, Ho PC, Lam S, Woo J, Chiu HF, Goggins W, Zee B, Wong A, Mok H, Cheng WK, Fong C, Lee JS, Chan MH, Szeto SS, Lui VW, Tsoh J, Kwok TC, Chan IH, Lam CW. Curcumin effects on blood lipid profile in a 6-month human study. Pharmacol Res. 2007 Dec;56(6):509-14. doi: 10.1016/j.phrs.2007.09.013. Epub 2007 Sep 18.
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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.
Larry Baum, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Curcumin and ginkgo extract in people with Alzheimer's Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2008. 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 Hong Kong. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in isoprostane level in plasma (time frame: 1 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00164749, which also lists 2 linked publications.
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 30 Apr 2008; AzTrials last refreshed its copy on 7 Nov 2026.