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Home-Based Closed-Loop Auditory Stimulation to Enhance Slow-Wave Activity in MCI Due to Alzheimer's Disease: A Proof-of-Concept Study (Nana-Home)

24. června 2026 aktualizováno: Bitbrain

This proof-of-concept study explores whether long-term home-based closed-loop auditory stimulation during sleep enhances slow-wave activity (SWA) and yields preliminary efficacy signals in patients with amnestic mild cognitive impairment due to Alzheimer's disease (MCI-AD), confirmed by cerebrospinal fluid (CSF) biomarkers or positron emission tomography (PET).

The intervention is self-administered at participants' homes over an initial treatment period of 3 months, followed by a 1-month off-treatment (washout) period. Participants may then enter an optional extension phase consisting of 3 additional months of treatment followed by a second 1-month washout period, for a total study duration of up to 8 months.

Participants who complete the Nana-Lab Study (NCT07402590) may be invited to provide informed consent for screening and potential enrollment in this study. All enrolled participants receive nightly active treatment during intervention periods. This study does not include randomization or a sham control group.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Detailní popis

Alzheimer's disease (AD) is characterized by progressive cognitive decline and is preceded by a prodromal stage known as amnestic mild cognitive impairment due to AD (MCI-AD), in which early neurophysiological alterations are detectable. Among these, disruptions in sleep architecture-particularly reductions in slow-wave activity (SWA; ~0.5-4 Hz) and sleep spindle activity (~11-16 Hz)-have been associated with impaired memory consolidation and the progression of AD-related pathophysiological processes.

Closed-loop auditory stimulation during sleep (CLAS) is a non-invasive neuromodulation approach that delivers precisely timed auditory stimuli phase-locked to endogenous slow oscillations, with the aim of enhancing slow-wave activity and associated thalamocortical spindle dynamics. This targeted entrainment of sleep oscillations may improve sleep-dependent neural processes and represents a potential therapeutic strategy in the early stages of AD.

The present study is an open-label, single-arm investigation designed to evaluate the effects of home-based CLAS in patients with biomarker-confirmed amnestic mild cognitive impairment due to Alzheimer's disease (MCI-AD). The intervention is self-administered in the participants' home environment. All participants complete an initial treatment period of 3 months followed by a one-month off-treatment (washout) period to assess persistence of effects. Participants who elect to continue may then enter an optional extension phase consisting of 3 additional months of treatment, followed by a second one-month off-treatment period. The total study duration is approximately 4 months for participants completing the initial phase only, or approximately 8 months for those completing the extension phase.

The primary objective is to assess target engagement, defined as the modulation of NREM sleep electrophysiological activity, with particular focus on slow-wave sleep. More precisely, sustained increases in slow-wave activity across the intervention period will be quantified using the study EEG device during intervention nights.

Secondary objectives include evaluation of adherence to the intervention, usability of the device in the home environment, and safety and tolerability. Exploratory objectives include evaluation of the intervention's effects on clinical, functional, cognitive, and sleep-related outcomes, as well as blood-based biomarkers. Clinical, functional, and cognitive variables will be assessed at three time points: before intervention (baseline, Month 0), at the end of the initial treatment period (Month 3), and, for participants entering the extension phase, at the end of the extended treatment period (Month 7).

Blood biomarkers will be obtained at the following time points: baseline (Month 0), end of the initial treatment period (Month 3), and end of the first washout period (Month 4). Participants entering the extension phase will have two additional blood draws: at the end of the extended treatment period (Month 7) and at the end of the second washout period (Month 8). Sleep metrics, derived from EEG recordings or subjective responses to digitized questionnaires, will be acquired daily using the home-based study device.

This study does not include randomization or a sham control group; all participants receive active treatment during intervention periods. The results are expected to provide evidence on neurophysiological target engagement, feasibility, safety, and the clinical and biological effects of home-based CLAS as a therapeutic strategy in early-stage AD.

Typ studie

Intervenční

Zápis (Odhadovaný)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Španělsko
    • Zaragoza
      • Zaragoza, Zaragoza, Španělsko, 50006
        • Bit&Brain Technologies SL

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion criteria:

  • Age between 50 and 75 years (inclusive).
  • Spanish as native language.
  • Diagnosis of amnestic mild cognitive impairment due to Alzheimer's disease, confirmed by cerebrospinal fluid biomarkers or amyloid PET.
  • Normal or corrected-to-normal color vision (required for completion of visual-analog study assessments).
  • Adequate hearing to perceive the auditory stimuli used in the intervention, defined as a hearing threshold of 50 dB or below, assessed during the screening session.

Exclusion criteria:

  • Severe systemic or complex chronic disease that, in the investigator's judgment, would compromise participant safety or data quality, including but not limited to: advanced heart disease; advanced chronic kidney disease (stage 4 or 5); severe pulmonary disease (e.g., COPD GOLD stage III-IV); metastatic or terminal cancer; severe hematological disorders; or active or uncontrolled chronic infectious disease (e.g., untreated HIV).
  • Evidence on neuroimaging of strategic infarcts or other findings that may account for secondary cognitive impairment.
  • Alcohol or psychotropic substance abuse.
  • Diagnosis of depression or any severe psychiatric disorder within the 5 years prior to evaluation.
  • Changes in benzodiazepine or antidepressant treatment within the 6 months prior to baseline evaluation.
  • Current treatment with neuroleptics.
  • Epilepsy with active treatment within the last 5 years, or any neurological comorbidity that may cause cognitive impairment or structural brain damage.
  • Unable to read and write in Spanish.
  • Inability to use the study device effectively, as determined during the screening session. This includes, but is not limited to, anatomical or dermatological factors preventing adequate electrode placement, or excessive EEG signal artifacts that prevent reliable detection of sleep oscillations.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Auditory Stimulation Intervention Group
Participants receive closed-loop auditory stimulation during sleep at home for an initial treatment period of 3 months, followed by a 1-month off-treatment (washout) period. Participants may then enter an optional extension phase consisting of 3 additional months of treatment followed by a second 1-month washout period.
Přístroj: Closed-Loop Auditory Stimulation

The system delivers brief auditory stimuli (pink noise bursts) that are time-locked to the up-phase of endogenous slow oscillations during non-rapid eye movement (NREM) sleep, as detected in real time using electroencephalography (EEG). Stimulation is withheld in approximately half of detected slow oscillations (Sham) to serve as a within-session control condition for the acute effects of stimulation. The other half of the slow oscillations are stimulated at a volume between 30-60 dB (Stim), which is personalized to the patient and adapts during the night to improve response while reducing awakenings.

The objective of the stimulation is to enhance slow-wave activity (SWA) during deep sleep through phase-specific entrainment of endogenous slow-wave activity.

The intervention is self-administered using a portable system adapted for use in patients with MCI. Participants are instructed to use the device for as many nights as possible throughout the study period.

Ostatní jména:
  • AudiStim

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Target Engagement: Sustained Increase in Slow-Wave Activity During N2-N3 Sleep
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Within-subject difference in mean slow-wave activity during N2-N3 sleep between stimulation and sham conditions, computed nightly and aggregated across the intervention period. The sustained effect will be evaluated as the consistency of the stimulation-induced increase in slow-wave activity across nights throughout the intervention period.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sustained Increase in Spindle Activity During N2-N3 Sleep
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Within-subject difference in spindle activity (spindle occurrence during N2-N3 sleep) between stimulation and sham conditions, computed nightly and aggregated across the intervention period. The sustained effect will be evaluated as the consistency of the stimulation-induced increase in spindle activity across nights throughout the intervention period.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Adherence to the Intervention
Časové okno: Computed as a summary measure over each participant's full intervention period (3 months, or up to 7 months for participants entering the extension phase).
Average number of intervention nights attempted per week. An intervention night is defined as a night during which the participant initiates use of the technology. Adherence will also be summarized as the proportion of participants achieving an average of at least 4 nights per week.
Computed as a summary measure over each participant's full intervention period (3 months, or up to 7 months for participants entering the extension phase).
Usability of the Closed-Loop Auditory Stimulation System
Časové okno: Computed as a summary measure over each participant's full intervention period (3 months, or up to 7 months for participants entering the extension phase).
Percentage of successful sessions among all attempted sessions. A successful session is defined as one in which the participant correctly sets up the device, the system initializes, and usable physiological data are recorded. Sessions may be unsuccessful due to patient-side factors (e.g., electrode placement errors), device-side factors (e.g., technical malfunction), or both.
Computed as a summary measure over each participant's full intervention period (3 months, or up to 7 months for participants entering the extension phase).
Safety and Tolerability
Časové okno: Continuously monitored from enrollment through the end of participation, with summary analyses at 3 months and, for participants entering the extension phase, at 7 months.
Incidence, severity, and relatedness of adverse events associated with the intervention, including sleep disturbance, discomfort related to auditory stimulation, and any device-related adverse effects. Safety will be assessed continuously and summarized at interim and final analyses.
Continuously monitored from enrollment through the end of participation, with summary analyses at 3 months and, for participants entering the extension phase, at 7 months.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cognitive Performance - Alzheimer's Disease Assessment Scale-Cognitive Subscale, 11-item version (ADAS-Cog 11)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in global cognitive performance, as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11-item version (ADAS-Cog 11). Scores range from 0 to 70, with higher scores indicating poorer cognitive performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Functional Ability - Alzheimer's Disease Cooperative Study-Activities of Daily Living scale for Mild Cognitive Impairment (ADCS-ADL-MCI)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in activities of daily living measured using the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale for Mild Cognitive Impairment (ADCS-ADL-MCI). Scores range from 0 to 69; higher scores indicate better functional ability.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Global Cognition - MoCA
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in global cognitive function, as measured by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Episodic Memory - Rey Auditory Verbal Learning Test (RAVLT) Total Learning Score (Trials 1-5)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in episodic memory performance, assessed using the Rey Auditory Verbal Learning Test (RAVLT) total learning score (Trials 1-5). Scores range from 0 to 75, with higher scores indicating better episodic memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Immediate Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory I
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in immediate memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory I subtest. Scores range from 0 to 53, with higher scores indicate better immediate memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Episodic Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory II
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Change from baseline in episodic memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory II subtest. Scores range from 0 to 39, with higher scores indicate better episodic memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Immediate Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates I
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Change from baseline in immediate memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates I subtest. Scores range from 0 to 40, with higher scores indicate better immediate memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Episodic Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates II
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in episodic memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates II subtest. Scores range from 0 to 10, with higher scores indicate better episodic memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Visual Reproduction - Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction I
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Change from baseline in visual memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction I subtest. Scores range from 0 to 43, with higher scores indicating better visual memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Visual Reproduction - Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction II
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Change from baseline in visual memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction II subtest. Scores range from 0 to 43, with higher scores indicating better visual memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Working Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Symbol Span
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Change from baseline in working memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Symbol Span subtest. Scores range from 0 to 50, with higher scores indicating better working memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Working Memory - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in working memory, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span subtest. Scores range from 0 to 48, with higher scores indicating better working memory performance
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Working Memory - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Arithmetic
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Change from baseline in working memory, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Arithmetic subtest. Scores range from 0 to 22, with higher scores indicating better working memory performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Processing Speed - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Symbol Search
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Change from baseline in processing speed, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Symbol Search subtest. Scores range from 0 to 60, with higher scores indicating better processing speed performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)
Processing Speed - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Coding
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in processing speed, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Coding subtest. Scores range from 0 to 135, with higher scores indicating better processing speed performance.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Anxiety Symptoms - Goldberg Anxiety Scale
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in anxiety symptoms, measured using the Goldberg Anxiety Scale. Scores range from 0 to 9, with higher scores indicating worse anxiety symptoms.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Depressive Symptoms - PHQ-8
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in depressive symptoms, measured using the Patient Health Questionnaire-8 (PHQ-8). Scores range from 0 to 24, with higher scores indicating greater symptom severity.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Patient Self-Reported Experience (Daily)
Časové okno: Assessed daily on intervention days, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Daily subjective cognitive and affective experience assessed using Temporal Experience Tracing (TET). TET is a visual-analog method in which participants retrospectively graph the intensity of an experience along several phenomenological dimensions over time, producing daily compositional profiles of cognitive and emotional states.
Assessed daily on intervention days, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Sleep macrostructure - Sleep duration
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

Change from baseline in sleep duration, estimated from EEG recordings. The duration of sleep will be quantified as the Time In Bed (TIB), defined as the full length from the start to the end of the recording; Sleep Period Time (SPT), from the first to the last epoch of sleep; and Total Sleep Time (TST), the cumulative duration of all sleep stages (N1, N2, N3, and REM). Sleep duration will be quantified in minutes.

Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard, obtaining the sleep stage for each 30-sec epoch of the recording.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Sleep macrostructure - Percentage of Time per Sleep Stage
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

Change from baseline in the distribution of sleep stages (%): N1, N2, N3, REM, Wake, estimated from EEG recordings. The time spent in each sleep stage will be reported with respect to sleep time, in percentage.

Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard, obtaining the sleep stage for each 30-sec epoch of the recording.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Sleep macrostructure - Efficiency of sleep
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

Change from baseline in efficiency of sleep, estimated from EEG recordings. Sleep Efficiency (SE) constitutes the ratio between total sleep time and time in bed, whereas Sleep Maintenance Efficiency (SME) is the ratio between total sleep time and sleep period time, representing the proportion of time spent alseep.

Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard, obtaining the sleep stage for each 30-sec epoch of the recording.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Sleep macrostructure - Wake after sleep onset
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

Change from baseline in time spent awake after the onset of sleep, estimated from EEG recordings. Wake After Sleep Onset (WASO) is the accumulated wake time (in minutes) within sleep period time.

Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard, obtaining the sleep stage for each 30-sec epoch of the recording.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Sleep macrostructure - Sleep onset latency
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

Change from baseline in sleep onset latency, estimated from EEG recordings. Sleep Onset Latency (SOL) is the time in minutes from the start of the recording to the first epoch of sleep. This metric can also be computed for each individual sleep stage (N1, N2, N3, and REM), measured from the start of the recording to the first occurrence of that stage.

Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard, obtaining the sleep stage for each 30-sec epoch of the recording.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Sleep macrostructure - Sleep fragmentation
Časové okno: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

Change from baseline in sleep fragmentation, estimated from EEG recordings. Sleep fragmentation is measured as the number of sleep stage changes (i.e., the number of transitions between diferent stages) througout the night. The number of transitions from any sleep stage (N1, N2, N3, REM) to wake constitute the number of awakenings.

Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard, obtaining the sleep stage for each 30-sec epoch of the recording.
Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Subjective Sleep Quality - PSQI
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in self-reported sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Subjective Sleep Quality - ISI
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Change from baseline in insomnia severity, measured using the Insomnia Severity Index (ISI). Scores range from 0 to 28, with higher scores indicating more severe insomnia.
Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).
Daytime Sleepiness
Časové okno: Assessed daily on intervention days, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Daily self-reported daytime sleepiness assessed using the Stanford Sleepiness Scale (SSS). Scores range from 1 to 7, with higher scores indicating greater sleepiness.
Assessed daily on intervention days, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).
Plasma Amyloid Pathology - Amyloid-Beta 42/40 Ratio
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Change from baseline in plasma amyloid-beta 42/40 ratio, assessed to characterize within-subject temporal dynamics across intervention and washout periods. Higher values indicate a higher amyloid-beta 42/40 ratio.
Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Plasma Phosphorylated Tau 217 (p-tau217)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8)
Percent change from baseline in plasma phosphorylated tau 217 (p-tau217). Values will be reported as percent change (%), with negative values representing decreases and positive values representing increases relative to baseline.
Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8)
Plasma Neurodegeneration Biomarker - Glial Fibrillary Acidic Protein (GFAP)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Percent change from baseline in plasma glial fibrillary acidic protein (GFAP), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating GFAP levels relative to baseline.
Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Plasma Neurodegeneration Biomarker - Neurofilament Light Chain (NfL)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Percent change from baseline in plasma neurofilament light chain (NfL), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating NfL levels relative to baseline.
Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Plasma Inflammatory Biomarker - Interleukin-6 (IL-6)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8)
Percent change from baseline in plasma interleukin-6 (IL-6), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating IL-6 levels relative to baseline.
Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8)
Plasma Inflammatory Biomarker - Interleukin-10 (IL-10)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Percent change from baseline in plasma interleukin-10 (IL-10), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating IL-10 levels relative to baseline.
Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).
Plasma Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNF-alpha)
Časové okno: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).]
Percent change from baseline in plasma tumor necrosis factor alpha (TNF-alpha), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating TNF-alpha levels relative to baseline.
Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).]

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Bitbrain

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. července 2025

Primární dokončení (Odhadovaný)

30. listopadu 2026

Dokončení studie (Odhadovaný)

30. prosince 2026

Termíny zápisu do studia

První předloženo

15. června 2026

První předloženo, které splnilo kritéria kontroly kvality

24. června 2026

První zveřejněno (Aktuální)

29. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na INZERÁT

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Podmínky

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Drogové intervence

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Sponzor / Spolupracovníci

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