Effect of Astaxanthin on the Patients With Alzheimer Disease

Study Overview
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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.

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

Official Title
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Effect of Astaxanthin on the Patients With Alzheimer Disease

Conditions
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To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease

Intervention / Treatment
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* Dietary Supplement: Astaxanthin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer disease, Astaxanthin