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2024-515574-27-00RecruitingPhase 2

LONGITUDINAL STUDY OF THE POSITRON EMISSION TOMOGRAPHY (PET) TRACER FOR TAU 18F-PI-2620 IN INDIVIDUALS WITH DOWN SYNDROME

Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Next steps

Brief summary (registry, in English)

• Obtain information on the efficacy of 18F-PI-2620, measured longitudinally, in detecting tau pathology in AD associated with DS. • Evaluate the safety of 18F-PI-2620 in healthy subjects and subjects with Down syndrome.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
18 Jun 2024
Start date
3 Jul 2024
Lead sponsor
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
EU CT number
2024-515574-27-00
EudraCT number
2019-004634-41

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 80
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The exclusion criteria for all groups will be: 1. Failure to meet the inclusion criteria. 2. Severe depression (Geriatric Depression Scale score > 20). 3. History of stroke, Hachinski score > 4, or previous neurological or psychiatric illness. 4. Confirmed pregnancy or possibility of pregnancy at the time of study inclusion.
  • History of stroke, Hachinski score > 4, or previous neurological or psychiatric illness.

Other

  • Severe depression (Geriatric Depression Scale score > 20)
  • Confirmed pregnancy or possibility of pregnancy at the time of study inclusion.

Who the study is looking for

  • Men and women aged > 35 years.
  • Absence of cognitive complaints.
  • Normal neuropsychological examination with MMSE scores between 24 and 30, absence of subjective memory complaints or objective memory deficits (measured with the Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) with a scaled score of 8 or higher, and a clinical dementia rating (CDR) scale score of 0 (Morris 1993).
  • Understanding and acceptance of study procedures and signing an informed consent form (by the guardian and/or patient). Inclusion criteria for participants with DS: 1. Men and women diagnosed with DS > 35 years. 2. Intelligence quotient > 34 (equivalent to mild and moderate intellectual disability according to ICD-10 criteria). 3. Presence of a reliable informant. 4. Participants/legal guardians who sign the informed consent form for inclusion in the study.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital de la Santa Creu i Sant PauBarcelonaSpainRecruiting

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