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A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease (SAPHARY)

24. august 2026 opdateret af: Galimedix Therapeutics Inc

This Phase 2a study will evaluate the safety and tolerability of GAL-101 in approximately 100 participants with mild to moderate Alzheimer's disease associated with amyloid-beta pathology. Participants will be randomly assigned to receive either 1200 mg of GAL-101 salt or matching placebo tablets by mouth once daily for 28 days. Neither the participants nor the study team will know which treatment each participant receives during the study.

The study will also explore whether GAL-101 affects brain-wave activity measured using quantitative electroencephalography, Alzheimer's disease-related biomarkers in cerebrospinal fluid, and performance on cognitive tests. Blood and cerebrospinal fluid samples will be collected to evaluate how GAL-101 is absorbed and distributed in the body.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

GAL-101 oral was previously evaluated in a Phase 1 study in healthy adult and elderly participants (ClinicalTrials.gov Identifier: NCT07780604)

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or female participants aged 50 to 85 years, inclusive.
  • Clinical diagnosis of Alzheimer's disease at the mild or moderate dementia stage (Stages 4 or 5) according to the 2018 National Institute on Aging and Alzheimer's Association criteria
  • Evidence of amyloid-beta pathology based on cerebrospinal fluid biomarkers, amyloid-beta positron emission tomography, or plasma phosphorylated tau 217.
  • Evidence of cognitive decline during the previous year.
  • Availability of a reliable trial partner, caregiver, or legal representative who has contact with the participant for at least 10 hours per week and can support study participation.
  • Able and willing to provide informed consent and comply with study requirements.
  • In sufficiently good health, in the investigator's opinion, to participate in the study.
  • If receiving an acetylcholinesterase inhibitor or memantine, treatment must be at a stable dose for the protocol-specified period.

Exclusion Criteria:

  • A neurological, psychiatric, cerebrovascular, or other medical condition that could explain the participant's cognitive impairment, interfere with study assessments, or create an unacceptable safety risk.
  • Previous treatment with anti-amyloid-beta immunotherapy.
  • Participation in another interventional clinical study or receipt of an investigational drug within 3 months before screening.
  • Use of prohibited medications or substances that could affect cognition, electroencephalography assessments, safety, or interpretation of the study results.
  • Clinically significant or unstable cardiovascular, respiratory, renal, hepatic, metabolic, infectious, or malignant disease.
  • Active major depression, schizophrenia, bipolar disorder, or clinically significant suicide risk.
  • Known or suspected hypersensitivity to GAL-101, placebo, or their components.
  • A scalp condition that would prevent adequate electroencephalography assessment.
  • Inability to comply with the study schedule or procedures.
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GAL-101 1200 mg
Participants will receive two 600 mg GAL-101 salt tablets orally once daily for 28 days. Treatment may be administered with or without food.
Medicin: GAL-101 Salt
GAL-101 salt will be administered orally as two 600 mg tablets, for a total dose of 1200 mg once daily for 28 days. The tablets may be taken with or without food.
Placebo komparator: Placebo
Participants will receive two matching placebo tablets orally once daily for 28 days. Treatment may be administered with or without food.
Medicin: Placebo
Matching placebo will be administered orally as two tablets once daily for 28 days. The tablets may be taken with or without food.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events
Tidsramme: From the first dose through 4 weeks after the last dose, approximately 8 weeks
Number of participants who experience one or more adverse events following administration of GAL-101 salt or placebo.
From the first dose through 4 weeks after the last dose, approximately 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Global Alpha-Band Corrected Amplitude Envelope Correlation
Tidsramme: Baseline to the end of the 28-day treatment perio
Change from baseline in global alpha-band corrected amplitude envelope correlation (AEC-c), assessed using quantitative electroencephalography. AEC-c is used to evaluate functional connectivity and synaptic activity in the brain.
Baseline to the end of the 28-day treatment perio

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Galimedix Therapeutics Inc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

28. februar 2027

Primær færdiggørelse (Anslået)

30. april 2028

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

24. august 2026

Først indsendt, der opfyldte QC-kriterier

24. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GAL-101-C0202

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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