Effect of Astaxanthin on the Patients With Alzheimer Disease

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: To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Astaxanthin

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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)	All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years.	3 years
Clinical Dementia Rating (CDR)	All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.	3 years
Neuropsychiatric Inventory (NPI)	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]	Monitor possible adverse effects of Astaxanthin, namely bleeding, anemia, blood sugar, blood pressure, liver and renal functions.	3 years

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Collaborators: China Medical University, China

Study record dates

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: Alzheimer disease; Astaxanthin
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• 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