NCT05015374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

September 27, 2024

Status Verified

July 1, 2024

Enrollment Period

5.6 years

First QC Date

August 12, 2021

Last Update Submit

September 25, 2024

Conditions

To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease

Keywords

Alzheimer diseaseAstaxanthin

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

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

    3 years

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Astaxanthin

ACTIVE COMPARATOR

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

Dietary Supplement: Astaxanthin

Interventions

AstaxanthinDIETARY_SUPPLEMENT

350 mg/capsule (2mg Astaxanthin)

Astaxanthin
PlaceboDIETARY_SUPPLEMENT

Placebo

placebo

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≦ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 20, 2021

Study Start

November 14, 2018

Primary Completion

June 1, 2024

Study Completion

June 25, 2024

Last Updated

September 27, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Will not share individual participant data

Locations

TW(1)