A prospective, open, randomized, parallel controlled clinical trial of light therapy in the treatment of early and moderate Alzheimer's disease

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044344

Enrollment

Unknown

Registered

2021-03-17

Start date

2018-02-27

Completion date

Unknown

Last updated

2021-09-07

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

Conditions

Alzheimer's disease

Interventions

Experiment group:light therapy

Control group:No light therapy

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Aged 50-85 years; 2) All patients diagnoses are in accordance with (NINCDS/ADRD) regulations; 3) Brain MRI examination (within 6 months examination) meets this diagnosis, excluding the progressive structural central nervous system disease or progressive encephalopathy; 4) cognitive decline and/or memory impairment for at least 12 months; 5) HAMD = 10 points, GDS grade 3-5 (the inclusion patients with early and moderate Alzheimer's disease); 7) Standardized treatment with donepezil hydrochloride for at least 2 weeks without other interventions; 8) The patient has a fixed caregiver who is willing to accompany the patient to receive radiation treatment every day; 9) Agree to participate in this clinical trial, willing to maintain the original treatment plan during the trial, and have signed an informed consent.

Exclusion criteria

Exclusion criteria: 1) Complicated with infectious diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, and are currently active; 2) Severe arrhythmia (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, Atrial flutter, etc.) or patients with abnormal cardiac conduction above NYHA grade II; 3) Severe respiratory dysfunction caused by respiratory diseases; 4) Patients with liver disease or liver injury (ALT or AST > 2 times the upper limit of normal); 5) Patients with severe renal impairment or renal failure (serum creatinine > 1.5 times the upper limit of normal); 6) Patients with blood system diseases (such as leukemia, sepsis, etc.), malignant tumors or immunocompromised patient; 7) Subjects who have had a stroke in the past 2 years; 8) Other types of dementia, or nerves such as epilepsy, schizophrenia, major depression, Parkinson's disease, etc. Systemic disease 9) Patients with brain tumors; 10) Subjects suffering from severe visual or hearing impairment; 11) Alcohol dependence, drug or other drug addicts or those with addiction tendency; 12) Those who have participated in other drug trials within 2 months; 13) Patients considered unsuitable by the researchers.

Design outcomes

Primary

Measure	Time frame
ADAS-cog;	—

Secondary

Measure	Time frame
ADAS-cog and Score in each dimension;ADL;MMSE;NPI;CIBIC-plus;GDS;Brain MRI;EEG;Device performance evaluation;	—

Countries

China

Contacts

Public ContactYing Mao

Huashan Hospital, Fudan University

maoying@fudan.edu.cn+86 18602109152

Outcome results

None listed

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