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Clinical Efficacy and Safety of Deep Brain Stimulation in the Treatment of Alzheimer Disease: a randomized controlled trial

Clinical Efficacy and Safety of Deep Brain Stimulation in the Treatment of Alzheimer Disease: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022324
Enrollment
Unknown
Registered
2019-04-05
Start date
2019-04-04
Completion date
Unknown
Last updated
2019-04-08

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

Conditions

Alzheimer disease

Interventions

normal aged group:none
AD-sham-DBS group:sham-DBS
AD-DBS group:DBS

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: Normal elderly group: 1. Aged 55-80 years. 2. No cognitive impairment. 3. The Mini Mental State Examination (MMSE) score is not lower than the corresponding cultural level limit. AD-sham-DBS group and AD-DBS group: 1. Aged 55-80 years. 2. Conforms to the National Institute of Neurology, Communication Disorders and Stroke - Alzheimer's Disease and Related Diseases Association (NINCDS-ADRDA), the most likely diagnostic criteria for AD (1984). 3. Cognitive impairment: MMSE total score = 26 points. 4. CDR 0.5-2. 5. Diagnostic evidence of memory loss, memory loss for at least 6 months, and a progressive trend. 6. Stable use medication before screening for =3 months, and no plan to change medication within 12 months after randomization. 7. Signing informed consent.

Exclusion criteria

Exclusion criteria: Normal elderly group: 1. Have had nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.). 2. There are infections that can affect brain function (eg HIV, viral or bacterial meningitis/encephalitis). 3. Suffering from intracranial tumors or related medical history (eg, glioma and meningioma). 4. MRI scan contraindications. 5. The investigator believes that the subject is unlikely to complete the study. AD-sham- DBS Group and AD- DBS Group 1.Dementia caused by other causes: vascular dementia, central nervous system infections (such as AIDS, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, Lewy body dementia, traumatic dementia, and other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (such as subdural hematoma, brain tumors), endocrine system diseases (such as thyroid disease, parathyroid disease) or dementia caused vitamin deficiency or any other cause. 2. There are infections that can affect brain function (eg HIV, viral or bacterial meningitis/encephalitis). 3. Suffering from intracranial tumors or related medical history (eg, glioma and meningioma). 4. Suicide risk. 5. MRI scan contraindications. 6. The investigator believes that the subject is unlikely to complete the study.

Design outcomes

Primary

MeasureTime frame
Alzheimer's disease-related scale;Mental Behavior Rating Scale;Quality of life related scales;MRI data;PET-CT data;Scalp EEG;

Countries

China

Contacts

Public ContactZhang Jianguo
zjguo73@126.com+86 13601294613

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026