Effect of Astaxanthin on the Patients With Alzheimer Disease

Not Applicable

Completed

• Conditions: To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease
• Interventions: Dietary Supplement: Astaxanthin; Dietary Supplement: Placebo

• Registration Number: NCT05015374
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2018-11-14
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-15
• Study First Posted: 2021-08-20
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Astaxanthin	Astaxanthin	Compared the difference in adverse effects between Astaxanthin users and placebo group.
placebo	Placebo	Compared the difference of changes in psychometrics between Astaxanthin users and placebo group.

Primary Outcome Measures

Name	Time	Method
Mini-Mental State Examination (MMSE)	3 years	All participants receive MMSE when they are enrolled, and follow up annually for a total of 3 years.
Neuropsychiatric Inventory (NPI)	3 years	All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years.
Cognitive Ability Screening Instrument (CASI)	3 years	All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years.
Clinical Dementia Rating (CDR)	3 years	All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan