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

Capital Medical University

Status: Unknown

Conditions: Alzheimer Disease

Treatments: Device: DBS of the NbM, power on; Device: DBS of the fornix, power off; Device: DBS of the fornix, power on; Device: DBS of the NbM, power off

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03352739

XuanwuH

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 5 patient groups

DBS of the fornix, power on

Experimental group

Treatment:

Device: DBS of the fornix, power on

DBS of the NbM, power on

Experimental group

Treatment:

Device: DBS of the NbM, power on

DBS of the fornix, power off

Sham Comparator group

Treatment:

Device: DBS of the fornix, power off

DBS of the NbM, power off

Sham Comparator group

Treatment:

Device: DBS of the NbM, power off

Control group

No Intervention group

Description:

The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.