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)
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Beijing, Kina, 100053
- Rekruttering
- Xuanwu Hospital, Capital Medical University.
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Kontakt:
- Peng-Hu Wei, M.D.
- Telefonnummer: +86-18601986863
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: DBS of the fornix, power on
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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 |
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Eksperimentel: DBS of the NbM, power on
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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 |
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Sham-komparator: DBS of the fornix, power off
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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 |
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Sham-komparator: 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 |
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Ingen indgriben: Control group
The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cognitive outcome
Tidsramme: 12 months (from 1 month to 13 month after implantation)
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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)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Neuroplasticity outcome
Tidsramme: 12 months (from 1 month to 13 month after implantation)
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Protection of hippocampal volume revealed by magnetic resonance imaging (MRI).
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12 months (from 1 month to 13 month after implantation)
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Neuroplasticity outcome
Tidsramme: 12 months (from 1 month to 13 month after implantation)
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Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging.
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12 months (from 1 month to 13 month after implantation)
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Cognitive outcome
Tidsramme: 12 months (from 1 month to 13 month after implantation)
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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). |
12 months (from 1 month to 13 month after implantation)
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Functional outcome
Tidsramme: 12 months (from 1 month to 13 month after implantation)
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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). |
12 months (from 1 month to 13 month after implantation)
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Safety outcome
Tidsramme: 12 months (from 1 month to 13 month after implantation)
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Device/therapy related side effects or complications such as mortality an morbidity.
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12 months (from 1 month to 13 month after implantation)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
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Yderligere relevante MeSH-vilkår
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