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A study on the efficacy and safety of ergothioneine in aiding the improvement of mild cognitive impairment

A study on the efficacy and safety of ergothioneine in aiding the improvement of mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112606
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-11-19
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment

Interventions

Test group:Take 4 ergotamine capsules daily, 2 in the morning and 2 in the evening, continuously for 24 weeks.

Sponsors

Chaohu Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participants were informed of the experimental content and purpose, and signed an informed consent form. 2) Self-reported at least two symptoms (such as short-term memory decline, distraction, or decreased executive function) lasting >=3 months, and did not meet the diagnostic criteria for neurodegenerative diseases. 3) Montreal Cognitive Assessment (MoCA) score between 18 and 26 points (for those with 0.4 pg/mL.

Exclusion criteria

Exclusion criteria: 1) Significant cognitive decline, such as in patients with Alzheimer's disease (AD); 2) Currently undergoing chemotherapy/radiotherapy, or having disabilities or difficulties in hearing, vision, or communication; 3) Pregnant or breastfeeding women, or those planning to conceive within the next 3 months; 4) History or clinical signs of neurological or psychiatric disorders, such as brain tumors, major depression, schizophrenia, etc.; 5) Presence of serious cardiovascular, liver, kidney, or hematological diseases; 6) Recent ( <= 3 months) use of medications affecting cognition (e.g., cholinesterase inhibitors, sedative-hypnotics, antipsychotics); 7) Allergic to ergothioneine, maltodextrin, or other excipients used in the trial; 8) Participation in other similar clinical trials within the past 3 months; 9) Poor compliance or prone to being lost to follow-up; 10) Other conditions deemed unsuitable for participation in the trial by the researchers.

Design outcomes

Primary

MeasureTime frame
Neuropsychological Test Battery (NTB) Z-score;; Repeatable Battery for the Assessment of Neuropsychological Status (RBANS);;

Secondary

MeasureTime frame
Changes in Z-scores in specific areas (based on NTB sub-items);Montreal Cognitive Assessment (MoCA);Mini-Mental State Examination (MMSE);Clinical Dementia Rating Scale (CDR-SB);

Countries

China

Contacts

Public ContactZhang Kai

Chaohu Hospital of Anhui Medical University

zhangkai@ahmu.edu.cn+86 189 2110 4636

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026