Effect of Astaxanthin on the Patients With Alzheimer Disease

Kaohsiung Medical University

Status: Completed

Conditions: To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Astaxanthin

Study type: Interventional

Funder types: Other

Identifiers

NCT05015374

KMUHIRB- F(II)-20180054

Details and patient eligibility

About

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.

Full description

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

Enrollment: 46 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Astaxanthin

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Astaxanthin