Effect of Astaxanthin on the Patients With Alzheimer Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2024-06-25

Brief Summary

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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.

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Detailed Description

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

Conditions

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To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Astaxanthin

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

Group Type ACTIVE_COMPARATOR

Astaxanthin

Intervention Type DIETARY_SUPPLEMENT

350 mg/capsule (2mg Astaxanthin)

Interventions

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Astaxanthin

350 mg/capsule (2mg Astaxanthin)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No