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Completed

NCT Number: NCT05015374

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.

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Key information

Conditions

To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astaxanthin

Dietary Supplement

350 mg/capsule (2mg Astaxanthin)

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Mini-Mental State Examination (MMSE)

    Time frame: 3 years

    All participants receive MMSE when they are enrolled, and follow up annually for a total of 3 years.

  2. Cognitive Ability Screening Instrument (CASI)

    Time frame: 3 years

    All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years.

  3. Clinical Dementia Rating (CDR)

    Time frame: 3 years

    All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.

  4. Neuropsychiatric Inventory (NPI)

    Time frame: 3 years

    All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years.

Secondary outcomes

  1. Incidence of treatment-emergent adverse events [safety and tolerability]

    Time frame: 3 years

    Monitor possible adverse effects of Astaxanthin, namely bleeding, anemia, blood sugar, blood pressure, liver and renal functions.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • China Medical University, China

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2021
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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