Fornix and NbM as Targets of Stimulation In Alzheimer's Disease
FANTASIA
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)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Dec 2017
Typical duration for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2017
CompletedFirst Posted
Study publicly available on registry
November 24, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 11, 2018
October 1, 2017
2 years
November 16, 2017
January 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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)
12 months (from 1 month to 13 month after implantation)
Secondary Outcomes (5)
Neuroplasticity outcome
12 months (from 1 month to 13 month after implantation)
Neuroplasticity outcome
12 months (from 1 month to 13 month after implantation)
Cognitive outcome
12 months (from 1 month to 13 month after implantation)
Functional outcome
12 months (from 1 month to 13 month after implantation)
Safety outcome
12 months (from 1 month to 13 month after implantation)
Study Arms (5)
DBS of the fornix, power on
EXPERIMENTALDBS of the NbM, power on
EXPERIMENTALDBS of the fornix, power off
SHAM COMPARATORDBS of the NbM, power off
SHAM COMPARATORControl group
NO INTERVENTIONThe patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.
Interventions
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
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
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
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
Eligibility Criteria
You may qualify if:
- Subjects with informed consent;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuanwu Hospital, Beijinglead
- Beijing Pins Medical Co., Ltdcollaborator
Study Sites (1)
Xuanwu Hospital, Capital Medical University.
Beijing, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2017
First Posted
November 24, 2017
Study Start
December 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2020
Last Updated
January 11, 2018
Record last verified: 2017-10