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Clinical effect and quantitative susceptibility mapping evaluation on the integrated treatment for cognitive dysfunction in mild to moderate Alzheimer's disease

Clinical effect and quantitative susceptibility mapping evaluation on the integrated treatment for cognitive dysfunction in mild to moderate Alzheimer's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001328
Enrollment
Unknown
Registered
2025-07-02
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

alzheimer's disease

Interventions

Treatment Group:Donepezil Hydrochloride Tablets
Health Control:None

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 50-85 years; 2) Diagnosed by the criteria of Neurological Communicative Disorders and Stroke and the Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA); 3) Cognitive impairment based on the scores of the Chinese version of the Mini Mental State Examination (MMSE) (patients with mild to moderate Alzheimers disease 11=primary school degree=22 11=junior high school degree or above=26; 4) Magnetic resonance imaging (MRI) confirmation of atrophy of the hippocampus or the medial temporal lobe volume MRI manifestation of high possibility of Alzheimer Disease; 5) The Medial Temporal Lobe Atrophy Rating Scale (MTA-scale) score (=2 for those under 75 years and =3 for those over 75 years); 6) Voluntarily joining this study with informed consents.

Exclusion criteria

Exclusion criteria: 1) Cognitive impairment caused by other factors (e.g. vascular dementia dementia with Lewy bodies frontotemporal dementia hormone or metabolic abnormalities hypothyroidism folic acid or vitamin B12 deficiency delirium or other mental and emotional disorders (such as schizophrenia and depression)); 2) A serious heart condition hepatic disease renal system disease hematopoietic system disease or whole-body malnutrition; 3) Aphasia disturbance of consciousness or failure to cooperate with the related examinations due to physical disability; 4) Anticoagulant treatments such as warfarin or heparin; 5) Use of pacemakers or receiving acupuncture in the past 2 weeks; 6) Metal implants such as steel plates and pacemakers; 7) Suffering claustrophobia.

Design outcomes

Primary

MeasureTime frame
Alzheimer's Disease Assessment Scale-cognitive section (ADAS-cog);

Secondary

MeasureTime frame
Alzheimer's Disease Assessment Scale-cognitive section (ADAS-cog);Alzheimer's Disease Cooperative Study-activities of daily living (ADCS-ADL);Quality of Life-Alzheimer's disease (QOL-AD);Susceptibility from quantitative susceptibility mapping;

Countries

China

Contacts

Public ContactPei Jian

Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai China

longhuaacup@aliyun.com+86-021-64385700

Outcome results

None listed

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