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

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ClinicalTrials.gov Identifier: NCT03352739
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
Beijing Pins Medical Co., Ltd
Information provided by (Responsible Party):
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.

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Cognitive outcome [ Time Frame: 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 [ Time Frame: 12 months (from 1 month to 13 month after implantation) ]
    Protection of hippocampal volume revealed by magnetic resonance imaging (MRI).

  2. Neuroplasticity outcome [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months (from 1 month to 13 month after implantation) ]
    Device/therapy related side effects or complications such as mortality an morbidity.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352739


Contacts
Contact: Guo-Guang Zhao, M.D. +86-010-63037023 ggzhao@vip.sina.com

Locations
China
Xuanwu Hospital, Capital Medical University. Recruiting
Beijing, China, 100053
Contact: Peng-Hu Wei, M.D.    +86-18601986863      
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Beijing Pins Medical Co., Ltd

Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03352739     History of Changes
Other Study ID Numbers: XuanwuH
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: October 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders