NCT07191821Enrolling by invitationPhase 2
TSPO Modulation in AD
Modulation of Endothelial Function in Alzheimer's Disease by 18kDa Translocator Protein
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this study is to determine whether pharmacological modulation of TSPO (with XBD173, 90mg twice daily, orally, for 28 days) improves neurovascular coupling (NVC) in AD relative to placebo. The main questions it aims to answer are: Does pharmacological modulation of TSPO (with XBD173, 90mg twice daily, orally, for 28 days) improve neurovascular coupling (NVC) in people with AD compared to placebo? NVC will be defined as the change in hippocampal cerebral blood flow (CBF) that follows a memory task (ΔCBF(h)). Does pharmacological modulation of TSPO (with XBD173, 90mg twice daily, orally, for 28 days): Increase cerebral blood flow (CBF); Reduce blood brain barrier leak (rate and volume) determined by Gd enhanced DCE-MRI; Increase plasma Amyloid 40/42; Reduce soluble markers of endothelial cell activation(sVCAM1, sICAM1, PECAM1, E-selectin, vWF); Improve markers of peripheral endothelial cell function; Cerebrovascular reactivity in response to CO2 inhalation The first six participants will undergo a dose escalation phase. The first 3 participants will receive XBD173 (90mg, once daily, 28 days) and the subsequent 3 participants will receive XBD173 (90mg, twice daily, 28 days). This phase will be open label. Participants will have 1 safety visits and 2 assessment visits. Each Assessment visit will involve clinical tests, a blood test and an MRI scan. Participants in the Randomisation phase participants will be given either 90mg of XBD173, twice daily or a placebo (dummy drug) for 4 weeks, have 2 safety visits and 4 assessment visits. Each Assessment visit will involve clinical tests, a blood test and an MRI scan. Healthy Volunteers will be recruited and undergo a screening visit and MRI scan.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 8 Aug 2025
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Imperial College London
- Diseases
- Alzheimer disease
- NCT number
- NCT07191821
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 51
- From 8 Aug 2025 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change of medications approved for AD (eg. Galantamine, rivastigmine, and donepezil) or antihypertensives within the last 28 days or planned during the timeframe of the study
- Use of the following medications or therapies:
- Severe and moderate P450 CY3A4 inhibitors: Boceprevir, Clarithromycin, Cobicistat, Idelalisib, Itraconazole, Ketoconazole, Nelfinavir, Ritonavir, Saquinavir, Telaprevir, Telithromycin, Voriconazoleb, Aprepitant, Conivaptan, Crizotinib, Diltiazem, Dronedarone, Erythromycin, Fluconazole, Imatinib, Isavuconazole, Nefazodone, Netupitant, Nilotinib, Posaconazolee, Tofisopam, Verapamil, Delavirdine
Other illness
- History of migraine (with attack frequency greater than 1 per month)
- Clinical history of suggestive of dementia with Lewy Bodies such as REM Sleep Behaviour Disorder
- Conditions affecting safe engagement in the intervention
- Conditions preventing completion of study procedures, e.g. severe loss of vision or hearing
- Severe respiratory disease with chronic hypoxia (sats \<92%), known CO2 retention or need for home oxygen therapy
- Severe respiratory disease with chronic hypoxia (sats \<92%), known CO2 retention or need for home oxygen therapy
Lab values
- Clinically significant renal disease (eGFR \<60 ml/min per 1.73m2)
- Clinically significant liver disease (abnormal serum transaminases)
- eGFR\<60 ml/min per 1.73 m2
Other
- Contraindications to MRI scanning or exposure to gadolinium-based contrast agents
- Severe and moderate P450 CY3A4 inducers: Carbamazepine, Enzalutamide, Fosphenytoin, Mitotane, Phenytoin, Rifampicin, Bosentan, Efavirenz, St John's wort, Barbiturates, Nevirapine, Primidone, Rifabutin, Rifapentine
- Oral contraceptives
- Contraindications to MRI scanning or exposure to gadolinium-based contrast agents
- Pregnancy in WOCBP
Who the study is looking for
- Subjects aged between 60-90 years old
- Male or postmenopausal female
- Fertile men are eligible to participate if they are willing to use the contraception methods listed in the PIS, during treatment and for 90 days after the last dose of treatment
- Able to provide written informed consent prior to any study-mandated procedures
- AA genotype at rs6971 (TSPO) locus
- Clinical diagnosis of AD by dementia specialist, fulfilling NIA-AA criteria
- Mild - moderate cognitive impairment (MMSE = 20-27 )
- AD biomarker positive MCI patients
- Subjects aged 18 years or older
- Male or Female
- Female subjects of childbearing potential must be willing to have a pregnancy test before scanning
- Able to provide written informed consent prior to any study-mandated procedures
- Subjects willing to have blood samples collected for genotyping (ApoE and TSPO rs6971)
- AD biomarker positive
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NIHR Imperial CRF Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.