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)
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Beijing, China, 100053
- Rekrutierung
- Xuanwu Hospital, Capital Medical University.
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Kontakt:
- Peng-Hu Wei, M.D.
- Telefonnummer: +86-18601986863
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Schein-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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Schein-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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Kein Eingriff: Control group
The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Cognitive outcome
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Neuroplasticity outcome
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- XuanwuH
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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