To Evaluate the Possible Benefit of Astaxanthin on Alzheimer DiseaseNCT05015374
Effect of Astaxanthin on the Patients With Alzheimer Disease
A study testing Astaxanthin in people with To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
This study adapts a randomized, double-blind, placebo-controlled trial, to exam the possible benefit of Astaxanthin on Alzheimer disease. The enrolled Alzheimer patients will take Astaxanthin or placebo for 1 year. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease
- What is being tested?
- Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Nov 2018to 25 Jun 2024
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 ≦ age ≦ 90
- Clinical Dementia Rating Scale = 0.5 or 1
- Under treatment with donepezil、rivastigmine or galantamine with good medical adherence
- Get a signed informed consent from the patient or his/her family
Who cannot join
- Not using or poor medical adherence to donepezil、rivastigmine or galantamine
- Combined using memantine or other cerebral perfusion enhancing agent, such as Piracetam, Dihydroergotoxine, Nicergoline etc.
- New cerebrovascular disease happens during 3-year follow up
- Mixed type dementia
- Major psychiatric disease (such as depression, bipolar disorder, schizophrenia) or substance abuser (such as alcohol, illegal drug, hypnotics)
- Heart failure, end stage renal disease, liver cirrhosis, or other major organ failure
- Severe hearing impairment results in incomplete survey of neuropsychatric evaluation
- No informed consent or no regular follow up
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
About this study
This study adapts a randomized, double-blind, placebo-controlled trial, to exam the possible benefit of Astaxanthin on Alzheimer disease. The enrolled Alzheimer patients will take Astaxanthin or placebo for 1 year. We will follow up Mini-Mental State Examination, Cognitive Ability Screening Instrument, Clinical Dementia Rating, and Neuropsychiatric Inventory at the end of the study.
Read the detailed description
This study aims to examine the benefit of Astaxanthin as adjuvant therapy for Alzheimer's disease.
- Being tested
- Astaxanthin, Placebo
- Keywords
- Alzheimer disease, Astaxanthin
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDietary supplement
350 mg/capsule (2mg Astaxanthin)
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Compared the difference of changes in psychometrics between Astaxanthin users and placebo group. Receives: Dietary Supplement: Placebo |
| Astaxanthin | Active comparator | Compared the difference in adverse effects between Astaxanthin users and placebo group. Receives: Dietary Supplement: Astaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
All participants receive MMSE when they are enrolled, and follow up annually for a total of 3 years.
Measured: 3 years
Cognitive Ability Screening Instrument (CASI)
All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years.
Measured: 3 years
Clinical Dementia Rating (CDR)
All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.
Measured: 3 years
Neuropsychiatric Inventory (NPI)
All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years.
Measured: 3 years
Secondary outcomes (1)
Incidence of treatment-emergent adverse events [safety and tolerability]
Monitor possible adverse effects of Astaxanthin, namely bleeding, anemia, blood sugar, blood pressure, liver and renal functions.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start14 Nov 2018
- Primary completion1 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Possible Benefit of Astaxanthin on Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015374
- Sponsor's protocol ID
- KMUHIRB- F(II)-20180054
- Status last verified
- Jul 2024
- First submitted
- 12 Aug 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Astaxanthin on the Patients With Alzheimer Disease
- ClinicalTrials.gov ID
- NCT05015374
- Acronym / sponsor ID
- KMUHIRB- F(II)-20180054
- Keywords
- Alzheimer disease, Astaxanthin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 20 Aug 2021 (actual)
- 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.
This study adapts a randomized, double-blind, placebo-controlled trial, to exam the possible benefit of Astaxanthin on Alzheimer disease. The enrolled Alzheimer patients will take Astaxanthin or placebo for 1 year. We will follow up Mini-Mental State Examination, Cognitive Ability Screening Instrument, Clinical Dementia Rating, and Neuropsychiatric Inventory at the end of the study.
Detailed description
This study aims to examine the benefit of Astaxanthin as adjuvant therapy for Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: PlaceboCompared the difference of changes in psychometrics between Astaxanthin users and placebo group. |
| Astaxanthin | Active comparator | Dietary Supplement: AstaxanthinCompared the difference in adverse effects between Astaxanthin users and placebo group. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 ≦ age ≦ 90
- Clinical Dementia Rating Scale = 0.5 or 1
- Under treatment with donepezil、rivastigmine or galantamine with good medical adherence
- Get a signed informed consent from the patient or his/her family
Key exclusion criteria (8 listed)
- Not using or poor medical adherence to donepezil、rivastigmine or galantamine
- Combined using memantine or other cerebral perfusion enhancing agent, such as Piracetam, Dihydroergotoxine, Nicergoline etc.
- New cerebrovascular disease happens during 3-year follow up
- Mixed type dementia
- Major psychiatric disease (such as depression, bipolar disorder, schizophrenia) or substance abuser (such as alcohol, illegal drug, hypnotics)
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 |
|---|---|---|
| Astaxanthin350 mg/capsule (2mg Astaxanthin) | Dietary supplement | Astaxanthin |
| PlaceboPlacebo | Dietary supplement | placebo |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: 3 years
All participants receive MMSE when they are enrolled, and follow up annually for a total of 3 years.
Cognitive Ability Screening Instrument (CASI)
Time frame: 3 years
All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years.
Clinical Dementia Rating (CDR)
Time frame: 3 years
All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.
Neuropsychiatric Inventory (NPI)
Time frame: 3 years
All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years.
1 secondary outcome
Incidence of treatment-emergent adverse events [safety and tolerability]
Time frame: 3 years
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 27 Sep 2024.
- Individual participant dataSharing planned: No. Will not share individual participant data
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin in people with To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 8 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 27 Sep 2024. 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 Taiwan. 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 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?
Mini-Mental State Examination (MMSE) (time frame: 3 years). The study lists 4 primary outcomes in all. 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 27 Sep 2024.