Fornix and NbM as Targets of Stimulation In Alzheimer's Disease

Not Applicable

• Conditions: Alzheimer Disease
• Interventions: Device: DBS of the NbM, power on; Device: DBS of the fornix, power on; Device: DBS of the NbM, power off; Device: DBS of the fornix, power off

• Registration Number: NCT03352739
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

The primary goal of this study is to evaluate the efficacy and safety of the DBS to the fornix/NbM among patients who are diagnosed as AD according to a series of evaluations including cerebrospinal fluid (CSF) biomarkers and molecular imaging examinations; The secondary goal is to compare the efficacy among the two treatment groups of different targets.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Study Start: 2017-12-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-11
• Primary Completion: 2019-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subjects with informed consent;
2. 45-75 years of age;
3. At least 6 years of education;
4. AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011);
5. Clinical Dementia Rating Scale (CDR): 1.0-2.0;
6. Positive findings with amyloid PET imaging;
7. Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period.

Exclusion Criteria

1. Fazekas scale>2;
2. Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4；
3. Modified Hachinski ischemic score>4；
4. Young Mania Rating Scale>11(Young, Biggs, Ziegler, & Meyer, 1978);
5. Any suicidal tendencies in recent 2 years;
6. Cornell Scale for Depression and Dementia>10;
7. Familial AD;
8. Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
9. Surgical history of the central nervous system;
10. Severe cardiovascular/pulmonary disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBS of the NbM, power on	DBS of the NbM, power on	-
DBS of the fornix, power on	DBS of the fornix, power on	-
DBS of the NbM, power off	DBS of the NbM, power off	-
DBS of the fornix, power off	DBS of the fornix, power off	-

Primary Outcome Measures

Name	Time	Method
Cognitive outcome	12 months (from 1 month to 13 month after implantation)	Cognitive function measured by Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 13-items version).; ADAS-cog 13 scale range: 0-80; (Higher value represents a worse outcome)

Secondary Outcome Measures

Name	Time	Method
Neuroplasticity outcome	12 months (from 1 month to 13 month after implantation)	Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging.
Cognitive outcome	12 months (from 1 month to 13 month after implantation)	Improvement of cognitive function evaluated by Clinical Dementia Rating Scale sum of the boxes (CDR-SB).; CDR-SB scale range: 0-18; ("0" represents normal cognition, the higher the score, the worse the cognitive function).
Safety outcome	12 months (from 1 month to 13 month after implantation)	Device/therapy related side effects or complications such as mortality an morbidity.
Functional outcome	12 months (from 1 month to 13 month after implantation)	Improvement of life quality according to Activities of Daily Living (ADL) scale.; ADL scale range: 20-80 ("20" represents normal life ability, the higher the score, the worse the life ability).

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University.; 🇨🇳 Beijing, China