The Effects of Chicken Extract and a Peptide Supplement for the Prevention of Cognitive Decline in Non-demented Elderly Adults

Brand's Suntory Asia

Status and phase: Completed; Early Phase 1

Conditions: Aging; Mild Cognitive Impairment; Cognitive Decline

Treatments: Dietary Supplement: Peptide Supplement; Other: Placebo; Dietary Supplement: Chicken extract supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04555655

BEC-CMI-003

Details and patient eligibility

About

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.

Enrollment: 276 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 3 patient groups, including a placebo group

Chicken extract supplement

Experimental group

Treatment:

Dietary Supplement: Chicken extract supplement

Peptides supplement

Experimental group

Treatment:

Dietary Supplement: Peptide Supplement

Placebo

Placebo Comparator group

Treatment:

Other: Placebo