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PDE5 Inhibitor for Alzheimer's Disease

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Alzheimer's disease is the most common cause of dementia in the elderly population. The disease is characterised by the presence of abnormal proteins in the brain, primarily β-amyloid (Aβ) and tau. Recent evidence suggests that Phosphodiesterase-5 (PDE-5) enzyme inhibitors may hold therapeutic promise in the treatment of early AD. Findings showed that daily low-dose tadalafil (a PDE5 inhibitor that can cross the BBB) administration in patients with erectile dysfunction and MCI increased relative regional cerebral blood flow in the postcentral gyrus, precuneus, and brainstem. However, the long-term effects of tadalafil on AD progression and biomarkers are not known. However, there is limited evidence regarding its safety and efficacy in AD patients. The primary objective of this study is to assess the safety and tolerability of long-term (1 year) tadalafil treatment in patients who are Aβ-positive MCI and early AD based on NIA-AA criteria. Additionally, the secondary objective of this study is to assess the change in cognitive performance from baseline to follow-up, evaluated using neuropsychometric testing, in MCI and AD patients who are undergoing treatment with tadalafil for 1 year.
Trial Details
NCT Number NCT07172815
Lead Sponsor Imperial College London
Conditions Alzheimer Disease
Enrollment 244 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov