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Effect of Astaxanthin on the Patients With Alzheimer Disease

Primary Purpose

To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease

Status

Active

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Astaxanthin

Placebo

About this trial

This is an interventional treatment trial for To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease focused on measuring Alzheimer disease, Astaxanthin

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Astaxanthin

Arm Description

Compared the difference of changes in psychometrics between Astaxanthin users and placebo group.

Compared the difference in adverse effects between Astaxanthin users and placebo group.

Outcomes

Primary Outcome Measures

Mini-Mental State Examination (MMSE)

All participants receive MMSE when they are enrolled, and follow up annually for a total of 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.

Clinical Dementia Rating (CDR)

All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.

Neuropsychiatric Inventory (NPI)

All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05015374

First Posted

August 12, 2021

Last Updated

October 2, 2023

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

China Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT05015374

Brief Title

Effect of Astaxanthin on the Patients With Alzheimer Disease

Official Title

Effect of Astaxanthin on the Patients With Alzheimer Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 14, 2018 (Actual)

Primary Completion Date

September 15, 2023 (Actual)

Study Completion Date

June 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

China Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease

Keywords

Alzheimer disease, Astaxanthin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Compared the difference of changes in psychometrics between Astaxanthin users and placebo group.

Arm Title

Astaxanthin

Arm Type

Active Comparator

Arm Description

Compared the difference in adverse effects between Astaxanthin users and placebo group.

Intervention Type

Dietary Supplement

Intervention Name(s)

Astaxanthin

Intervention Description

350 mg/capsule (2mg Astaxanthin)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Mini-Mental State Examination (MMSE)

Description

All participants receive MMSE when they are enrolled, and follow up annually for a total of 3 years.

Time Frame

3 years

Title

Cognitive Ability Screening Instrument (CASI)

Description

All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years.

Time Frame

3 years

Title

Clinical Dementia Rating (CDR)

Description

All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.

Time Frame

3 years

Title

Neuropsychiatric Inventory (NPI)

Description

All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events [safety and tolerability]

Description

Monitor possible adverse effects of Astaxanthin, namely bleeding, anemia, blood sugar, blood pressure, liver and renal functions.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Kaohsiung Medical University Chung-Ho Memorial Hospital

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Will not share individual participant data

Learn more about this trial

Effect of Astaxanthin on the Patients With Alzheimer Disease

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