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

• Sponsor: Xuanwu Hospital, Beijing (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03352739
• Collaborator: Beijing Pins Medical Co., Ltd (Industry)
• Enrollment: 30
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Device: DBS of the fornix, power on; Device: DBS of the NbM, power on; Device: DBS of the fornix, power off; Device: DBS of the NbM, power off	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Study of 12 Months to Evaluate the Safety and Efficacy of Deep Brain Stimulation(DBS) to the Fornix & Meynert Nucleus(NbM) in Patients With Mild to Moderate Alzheimer's Disease(AD)
• Actual Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DBS of the fornix, power on	Device: DBS of the fornix, power on; DBS of bilateral columns of the fornix is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on . DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
Experimental: DBS of the NbM, power on	Device: DBS of the NbM, power on; DBS of bilateral NbMs is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on . DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
Sham Comparator: DBS of the fornix, power off	Device: DBS of the fornix, power off; DBS of bilateral columns of the fornix is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation. DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
Sham Comparator: DBS of the NbM, power off	Device: DBS of the NbM, power off; DBS of bilateral NbMs is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation. DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead
No Intervention: Control group The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.

Outcome Measures

Primary Outcome Measures

1. 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

1. Neuroplasticity outcome [12 months (from 1 month to 13 month after implantation)]

   Protection of hippocampal volume revealed by magnetic resonance imaging (MRI).

2. Neuroplasticity outcome [12 months (from 1 month to 13 month after implantation)]

   Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging.

3. 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).

4. 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).

5. Safety outcome [12 months (from 1 month to 13 month after implantation)]

   Device/therapy related side effects or complications such as mortality an morbidity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University.	Beijing		China	100053

Sponsors and Collaborators

• Xuanwu Hospital, Beijing
• Beijing Pins Medical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xuanwu Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT03352739
• Other Study ID Numbers: XuanwuH
• First Posted: Nov 24, 2017
• Last Update Posted: Jan 11, 2018
• Last Verified: Oct 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jan 11, 2018