NCT03115814

Brief Summary

To investigate the safety of deep brain stimulation in the treatment of severe Alzheimer's disease (AD); to investigate the effectiveness of deep brain stimulation in the treatment of severe AD, i.e., effects of deep brain stimulation on cognitive function in patients with severe AD and dementia grading; to investigate the effects of deep brain stimulation on cerebral glucose metabolism in patients with severe AD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 17, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

April 7, 2017

Last Update Submit

June 28, 2017

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Deep brain stimulation-related disability rates

    To assess the effectiveness of deep brain stimulation in the treatment of Alzheimer's disease (AD).

    changes of baseline and month 1, month 6, month 12 after surgery

Secondary Outcomes (3)

  • Clinical Dementia Rating(CDR) score

    changes of baseline and month 1, month 6, month 12 after surgery

  • The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog)

    changes of baseline and month 1, month 6, month 12 after surgery

  • Mini-Mental State Examination (MMSE) score

    changes of baseline and month 1, month 6, month 12 after surgery

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Six Patients with severe Alzheimer's disease (AD) scheduled to receive deep brain stimulation will be all recruited from the clinics and wards of Department of Neurosurgery, Chinese PLA General Hospital of China.

You may qualify if:

  • Meet the diagnosis criteria of AD formulated by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
  • MMSE score 0-10 points;
  • Age 40-80 years;
  • Provision of signed informed consent.

You may not qualify if:

  • Abnormal brain structure prior to surgery (tumor, cerebral infarction, intracranial hematoma)
  • Complicated by other neurological system disorders, such as multiple sclerosis and epilepsy;
  • Psychiatric disorders, such as anxiety, depression or drug-induced psychosis;
  • Severe internal diseases, are taking respiratory system drugs, cardiovascular drugs, anticonvulsants or psychotropic drugs;
  • Inability to tolerance clinical complications;
  • Severe auditory and visual disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Related Publications (2)

  • Xu J, Liu B, Shang G, Feng Z, Yang H, Chen Y, Yu X, Mao Z. Efficacy and Safety of Bilateral Deep Brain Stimulation (DBS) for Severe Alzheimer's Disease: A Comparative Analysis of Fornix Versus Basal Ganglia of Meynert. CNS Neurosci Ther. 2025 Apr;31(4):e70285. doi: 10.1111/cns.70285.

    PMID: 40243219DERIVED

  • Mao ZQ, Wang X, Xu X, Cui ZQ, Pan LS, Ning XJ, Xu BX, Ma L, Ling ZP, Jia JJ, Yu XG. Partial improvement in performance of patients with severe Alzheimer's disease at an early stage of fornix deep brain stimulation. Neural Regen Res. 2018 Dec;13(12):2164-2172. doi: 10.4103/1673-5374.241468.

    PMID: 30323149DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Zhiqi Mao, Ph.D

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiqi Mao, Ph.D

CONTACT

8618910155994markmaoqi@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 14, 2017

Study Start

April 17, 2017

Primary Completion

October 1, 2018

Study Completion

June 1, 2019

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

CN(1)