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

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DBS of the fornix, power on
DBS of the NbM, power on
DBS of the fornix, power off
DBS of the NbM, power off
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xuanwu Hospital, Capital Medical University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

No Intervention

Arm Label

DBS of the fornix, power on

DBS of the NbM, power on

DBS of the fornix, power off

DBS of the NbM, power off

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

Cognitive outcome
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

Neuroplasticity outcome
Protection of hippocampal volume revealed by magnetic resonance imaging (MRI).
Neuroplasticity outcome
Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging.
Cognitive outcome
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).
Functional outcome
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).
Safety outcome
Device/therapy related side effects or complications such as mortality an morbidity.

Full Information

First Posted
November 16, 2017
Last Updated
January 10, 2018
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Pins Medical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03352739
Brief Title
Fornix and NbM as Targets of Stimulation In Alzheimer's Disease
Acronym
FANTASIA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Pins Medical Co., Ltd

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBS of the fornix, power on
Arm Type
Experimental
Arm Title
DBS of the NbM, power on
Arm Type
Experimental
Arm Title
DBS of the fornix, power off
Arm Type
Sham Comparator
Arm Title
DBS of the NbM, power off
Arm Type
Sham Comparator
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.
Intervention Type
Device
Intervention Name(s)
DBS of the fornix, power on
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
DBS of the NbM, power on
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
DBS of the fornix, power off
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
DBS of the NbM, power off
Intervention Description
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
Primary Outcome Measure Information:
Title
Cognitive outcome
Description
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)
Time Frame
12 months (from 1 month to 13 month after implantation)
Secondary Outcome Measure Information:
Title
Neuroplasticity outcome
Description
Protection of hippocampal volume revealed by magnetic resonance imaging (MRI).
Time Frame
12 months (from 1 month to 13 month after implantation)
Title
Neuroplasticity outcome
Description
Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging.
Time Frame
12 months (from 1 month to 13 month after implantation)
Title
Cognitive outcome
Description
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).
Time Frame
12 months (from 1 month to 13 month after implantation)
Title
Functional outcome
Description
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).
Time Frame
12 months (from 1 month to 13 month after implantation)
Title
Safety outcome
Description
Device/therapy related side effects or complications such as mortality an morbidity.
Time Frame
12 months (from 1 month to 13 month after implantation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with informed consent; 45-75 years of age; At least 6 years of education; AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011); Clinical Dementia Rating Scale (CDR): 1.0-2.0; Positive findings with amyloid PET imaging; 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: Fazekas scale>2; Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4； Modified Hachinski ischemic score>4； Young Mania Rating Scale>11(Young, Biggs, Ziegler, & Meyer, 1978); Any suicidal tendencies in recent 2 years; Cornell Scale for Depression and Dementia>10; Familial AD; Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome; Surgical history of the central nervous system; Severe cardiovascular/pulmonary disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-Guang Zhao, M.D.
Phone
+86-010-63037023
Email
ggzhao@vip.sina.com
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University.
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng-Hu Wei, M.D.
Phone
+86-18601986863

12. IPD Sharing Statement

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

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