Oral Semaglutide in Patients With Alzheimer's Disease

Sponsor
Imperial College London
Study ID
NCT07200622
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide (Rybelsus®) — DRUG
    All subjects will receive oral semaglutide once daily (4-weekly dose escalation from 3 mg to 7 mg and finally 14 mg). This dose escalation schedule is specified in the IMP (Rybelsus) SmPC.
  • Placebo — DRUG
    Matched oral Placebo to be taken once daily.

Study Details

Alzheimer's disease (AD) is a progressive neurodegenerative disease and a major global healthcare burden. Currently, the disease is only treated symptomatically and an effective disease-modifying therapy (DMT) that may slow the disease progression, and prevent cognitive and functional deterioration, is yet to emerge. Glucagon-like peptide-1 (GLP-1) analogues are being studied to treat neurodegenerative diseases, due to evidence of their neuroprotective effects in mouse models of AD. This study investigates Semaglutide, a modified human GLP-1RA in Alzheimer's disease to understand the mechanism of the disease. The primary objective of this study is to evaluate the safety and tolerability of oral semaglutide in individuals with mild AD. Moreover, the secondary objective of the study is to evaluate the change in synaptic density using PET before and after treatment with semaglutide.

Key Dates

Start date
Sep 25, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide (Rybelsus)
  • Placebo Comparator: Placebo

Primary Outcome Measure

To evaluate the safety and tolerability of oral semaglutide in an AD population. [ Time Frame: Adverse events monitoring: Baseline; Weeks 4, 8, 26, 39, 52 ]

Central Contacts

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