To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease
Conditions
Keywords
Alzheimer disease, Astaxanthin
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.
Detailed description
This study aims to examine the benefit of Astaxanthin as adjuvant therapy for Alzheimer's disease.
Interventions
DIETARY_SUPPLEMENTAstaxanthin
350 mg/capsule (2mg Astaxanthin)
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
China Medical University, China
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination (MMSE) | 3 years | All participants receive MMSE when they are enrolled, and follow up annually for a total of 3 years. |
| Cognitive Ability Screening Instrument (CASI) | 3 years | All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years. |
| Clinical Dementia Rating (CDR) | 3 years | All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years. |
| Neuropsychiatric Inventory (NPI) | 3 years | All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events [safety and tolerability] | 3 years | Monitor possible adverse effects of Astaxanthin, namely bleeding, anemia, blood sugar, blood pressure, liver and renal functions. |
Countries
Taiwan
Outcome results
None listed