← Trials/Trial dossier/NCT07191821

Enrolling by invitationPhase 2

TSPO Modulation in AD

Modulation of Endothelial Function in Alzheimer's Disease by 18kDa Translocator Protein

Lead sponsor

Imperial College London

Asset

XBD173

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 20-27•MRI contraindications excluded

Primary endpoint

•Does pharmacological modulation of TSPO

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID23/LO/0080

NCT IDNCT07191821

Timeline

Milestones

Study start2025-08-08actual

Study first posted2025-09-25actual

Last update posted2025-10-01actual

Primary completion2027-03-01estimated

Study completion2027-06-01estimated

Assets

Drug assets

XBD173

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age90 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

for AD:

•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

Inclusion criteria for HV:

•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

Exclusion criteria

for AD:

•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

•Clinically significant renal disease (eGFR <60 ml/min per 1.73m2)

•Clinically significant liver disease (abnormal serum transaminases)

•Contraindications to MRI scanning or exposure to gadolinium-based contrast agents

•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

•Severe respiratory disease with chronic hypoxia (sats <92%), known CO2 retention or need for home oxygen therapy

•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

•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

Exclusion criteria for HV

•Contraindications to MRI scanning or exposure to gadolinium-based contrast agents

•Pregnancy in WOCBP

•eGFR<60 ml/min per 1.73 m2

•Severe respiratory disease with chronic hypoxia (sats <92%), known CO2 retention or need for home oxygen therapy

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Memory

1 endpoint

Primary/protocol endpoint

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?

Time frame:From baseline to 4 week follow-up after taking medication/placebo

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.