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Study on the neuroimmune mechanism of folic acid combined with DHA in improving cognitive decline

Study on the neuroimmune mechanism of folic acid combined with DHA in improving cognitive decline

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057965
Enrollment
Unknown
Registered
2022-03-24
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Mild Cognitive Impairment (MCI)

Interventions

DHA:DHA 1.2g/day, oral, 12 months
Folic acid:Folic acid, 800ug/day, oral, 12 months
DHA placebo
Folic acid + DHA:Folic acid, 800ug/day, oral, 12 months
DHA 1.2g/day, oral, 12 months
Control group:Folic acid placebo, oral, 12 months
DHA placebo, oral, 12 months

Sponsors

Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 65 years and older; 2. Subjective and objective examination with mild cognitive impairment; 3. Memory degeneration is greater than 3 months; 4. Cognitive impairment, that is, the score of the Simple Mental State Examination Scale (MMSE), the illiterate group <=17 points, the primary school group <=20 points, the middle school or above group <=24 points; 5. Life and social function decreased: ADL score <= 18 points, GDS 2-3 level; 6. Does not meet the dementia diagnosis criteria; 7. Excludes cognitive impairment caused by special causes.

Exclusion criteria

Exclusion criteria: 1. Brain tumors; 2. Parkinson's disease; 3. Other medical diseases with severe or unstable conditions can affect brain function or affect the evaluation of cognitive function; 4. History of acute cerebrovascular disease within 3 months; 5. Currently diagnosed with active epilepsy; 6. Have severe cognitive impairments that prevent those who are unable to complete cognitive function measurements; 7. Have depression, mania, delirium, a history of mental illness such as anxiety; 8. Those who have taken folic acid and DHA intervention agents for nearly one year are excluded.

Design outcomes

Primary

MeasureTime frame
Cognitive function;

Secondary

MeasureTime frame
Folic acid, DHA and metabolites;Aß40, Aß42, Blood lipids;Inflammatory factors;

Countries

China

Contacts

Public ContactHuan Liu

Tianjin Medical University

liuhuan@tmu.edu.cn+86 22 8333 6122

Outcome results

None listed

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