Effect of Astaxanthin on the Patients With Alzheimer Disease

September 25, 2024 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to examine the benefit of Astaxanthin as adjuvant therapy for Alzheimer's disease.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 60 ≦ age ≦ 90
  2. Clinical Dementia Rating Scale = 0.5 or 1
  3. Under treatment with donepezil、rivastigmine or galantamine with good medical adherence
  4. Get a signed informed consent from the patient or his/her family

Exclusion Criteria:

  1. Not using or poor medical adherence to donepezil、rivastigmine or galantamine
  2. Combined using memantine or other cerebral perfusion enhancing agent, such as Piracetam, Dihydroergotoxine, Nicergoline etc.
  3. New cerebrovascular disease happens during 3-year follow up
  4. Mixed type dementia
  5. Major psychiatric disease (such as depression, bipolar disorder, schizophrenia) or substance abuser (such as alcohol, illegal drug, hypnotics)
  6. Heart failure, end stage renal disease, liver cirrhosis, or other major organ failure
  7. Severe hearing impairment results in incomplete survey of neuropsychatric evaluation
  8. No informed consent or no regular follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Compared the difference of changes in psychometrics between Astaxanthin users and placebo group.
Dietary supplement: Placebo
Placebo
Active Comparator: Astaxanthin
Compared the difference in adverse effects between Astaxanthin users and placebo group.
Dietary supplement: Astaxanthin
350 mg/capsule (2mg Astaxanthin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events [safety and tolerability]
Time Frame: 3 years
Monitor possible adverse effects of Astaxanthin, namely bleeding, anemia, blood sugar, blood pressure, liver and renal functions.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2018

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 25, 2024

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 15, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB- F(II)-20180054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will not share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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