Clinical trial NCT04555655: The Effects of Chicken Extract and a Peptide Supplement for the Prevention of Cognitive Decline in Non-demented Elderly Adults
Official title: Trial of A Chicken Extract and Peptide Supplement for the Prevention of Cognitive Decline and Mechanisms of Action in Non-demented Elderly Adults: A Multicenter, Two-year, Three-arm, Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cognitive Decline
Mild Cognitive Impairment
Aging
Lead sponsor: Brand's Suntory Asia
Sponsor class: INDUSTRY
Collaborators: name: Taipei Medical University Shuang Ho Hospital
name: National Cheng-Kung University Hospital
name: Chang Gung Memorial Hospital
First posted: 2020-09-21
Enrollment: 276
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial investigates the effect of a chicken extract supplement and a peptide supplement on cognitive function and potential mechanisms of action of cognitive decline during ageing, among non-demented elderly adults using a three-arm, randomized, placebo-controlled clinical trial design.


Eligibility criteria: Inclusion Criteria:

* Male or female at 55 - 75 years of age
* Baseline cognition:
* Normal cognition with feelings of cognitive decline (subjective cognitive decline) OR
* Mild cognitive impairment (MCI+) with memory impairment
* Agree to participate in the study and provide written informed consent

Exclusion Criteria:

* Inadequate visual and auditory acuity to allow neuropsychological testing
* Significant cerebrovascular disease
* History of allergy to chicken meat
* Diagnosis of Alzheimer's disease (AD) with dementia or any other dementia
* Clinical dementia rating (CDR) score of \> 0.5 at screening
* Evidence of other neurological, psychiatric or physical illness that can produce cognitive deterioration per investigator's judgment
* Inability or unwillingness to undergo PET scan
* Current diagnosis or history of alcoholism or substance addiction
* Regular use of any medication in the past 6 months that may affect cognitive functioning
* Regular use of cognitive enhancing supplements in the past 6 months
* Subjects with excessive blood donation or blood drawn prior to baseline
* Persons with a history of cardiovascular disease or any other cardiovascular or cerebrovascular diseases which investigators deem unsuitable to participate in the clinical study.

Primary outcomes:
measure: Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS)
timeFrame: 24 months
measure: Florbetaben (18F) PET Scan Imaging
timeFrame: 24 months
Secondary outcomes:
measure: Handgrip strength
timeFrame: 12 months & 24 months
measure: Ratio of plasma tau protein and amyloid-beta 42
timeFrame: 24 months
measure: Alzheimer's Disease Composite Score (ADCOMS)
timeFrame: 12 months
measure: Blood myeloperoxidase (MPO) levels
timeFrame: 12 months & 24 months
measure: Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, IL-6)
timeFrame: 12 months & 24 months
measure: Fasting blood glucose level
timeFrame: 4, 8, 12, 18 and 24 months
measure: Taiwanese Depression Questionnaire (TQD) score
timeFrame: 4, 8, 12, 18 and 24 months
measure: Short Form-36 (SF-36) Component and Scale Scores
timeFrame: 4, 8, 12, 18 and 24 months
measure: Athens Insomnia Scale (AIS)
timeFrame: 4, 8, 12, 18 and 24 months
measure: Incidence of infections
timeFrame: 24 months, reported at each study visit (4, 8, 12, 18 and 24 months)
measure: Cerebral blood flow measured with sonography
timeFrame: 12 months & 24 months
measure: Blood pressure (systolic blood pressure and diastolic blood pressure)
timeFrame: 4, 8, 12, 18 and 24 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Hospital Shuang Ho Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
References: