Non-pharmacological Intervention for Preclinical Alzheimer's Disease

Not Applicable

Completed

• Conditions: Functional Food; Alzheimer Disease; Subjective Cognitive Decline; Intervention; Neuroimaging

• Registration Number: NCT04279418
• Lead Sponsor: XuanwuH 2

Brief Summary

Alzheimer's disease (AD) is the most common form of neurodegenerative disorders leading to dementia. Currently, there has been no effective drugs targeting this disease. Functional food is considered as a potentially non-pharmacologic treatment. In this project, the investigators aim to investigate the effectiveness of a mixed functional food with main compositions of ginsenoside, green tea polyphenols and marine collagen peptide on cognition for individuals with subjective cognitive decline (SCD). Taking the randomized, double-blind, placebo-controlled method, participants in the functional food group will take mixed functional foods for three months and those in the placebo group will take placebo. After that, the investigators will investigate the changes of cognitive function. Furthermore, based on the neuroimaging technique, the regulatory mechanism of functional food in intervening SCD will be revealed from the perspective of altered brain functional activity. In conclusion, these results are beneficial for understanding the therapeutic effect of mixed functional foods as a non-drug treatment for early AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.

Detailed Description

Currently, there has been no effective therapy for Alzheimer's disease (AD). Functional food is now considered as a potentially non-pharmacologic intervention and supplementation of functional food may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of mixed functional foods with multiple compositions on cognition and neuroimaging biomarkers for subjective cognitive decline (SCD).

Sixty participants with SCD will be recruited in this three-month, randomized, double-blind, placebo-controlled trial. Each group had thirty participants. Participants in the functional food group will take mixed functional foods for three months and those in the placebo group will take placebo. After that, the investigators will investigate the changes of memory measures, which is the primary outcome. Furthermore, based on the neuroimaging technique of functional near-infrared spectroscopy (fNIRS), the regulatory mechanism of mixed functional foods in intervening SCD will be revealed from the perspective of altered brain functional activity.

In conclusion, these results are beneficial for understanding the therapeutic effect of mixed functional foods as a non-drug therapy for preclinical AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-16
• Study First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-19
• Study First Posted: 2020-02-21
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 50-79 years old, right-handed and Mandarin-speaking subjects;
• self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event;
• normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests;
• concerns (worries) associated with memory complaint;
• failure to meet the criteria for MCI or dementia

Exclusion Criteria

• a history of stroke;
• major depression (Hamilton Depression Rating Scale score > 24 points);
• other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy;
• cognitive impairment caused by traumatic brain injury;
• systemic diseases, such as thyroid dysfunction, syphilis and HIV;
• a history of psychosis or congenital mental growth retardation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of Auditory Verbal Learning Test (AVLT) score	Three months	After intervention for three months, the investigators will compare memory changes based on Auditory Verbal Learning Test (AVLT) scale in two groups, in order to investigate the therapeutic effectiveness of mixed functional foods supplementation. The scale of AVLT focuses on the memory domain, especially AVLT-long delayed memory, with cut-off points as 5 (50-59 years old), 4 (60-69 years old), 3 (70-79 years old) and AVLT-recognition, with cut-off points as 20 (50-59 years old), 19 (60-69 years old), 18 (70-79 years old). Higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
FNIRS-based brain functional activity changes	Three months	At baseline and post-intervention visits, the brain functional activity data will be collected using functional near-infrared spectroscopy (fNIRS) technique. The investigators will compare the changes of brain functional activity based on the measure of oxyhemoglobin concentration signal with relatively high signal to noise ratio (SNR) in two groups, in order to reveal the regulatory mechanism of mixed functional foods in intervening SCD persons.

Trial Locations

Locations (1)

Department of Neurolgy, Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China