Frontlight ResearchEarly access
Taking people in SpainPhase 2
Imaging Tau in Alzheimer Disease Linked to Down Syndrome
Tests a PET tracer that detects tau in adults with Down syndrome.
Key facts
- Who runs it
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Where
- Barcelona, SpainSee the site
- Registry title
- LONGITUDINAL STUDY OF THE POSITRON EMISSION TOMOGRAPHY (PET) TRACER FOR TAU 18F-PI-2620 IN INDIVIDUALS WITH DOWN SYNDROME
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 80 people, planned
- Started
- 3 Jul 2024
- Planned end
- 1 Oct 2025
- Type of study
- Interventional
- Record updated
- 19 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults over 35, both people with Down syndrome and healthy volunteers, to study a PET tau scan tracer (18F-PI-2620) over time.
- Age
- Older than 35 years (the registry also lists a minimum age of 18 years).
- Sex
- Men and women
- Disease stage
- No memory complaints, normal memory tests (MMSE score between 24 and 30) and a clinical dementia rating of 0. People with Down syndrome need an intelligence quotient above 34 (mild or moderate intellectual disability).
Main reasons for not taking part
- Severe depression (Geriatric Depression Scale score above 20)
- History of stroke, Hachinski score above 4, or earlier neurological or psychiatric illness
- Confirmed pregnancy or possible pregnancy
- No reliable informant (for people with Down syndrome)
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Severe depression (Geriatric Depression Scale score > 20)
- Confirmed pregnancy or possibility of pregnancy at the time of study inclusion
Where in Spain
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
About the trial
What the trial wants to find out
• 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- LONGITUDINAL STUDY OF THE POSITRON EMISSION TOMOGRAPHY (PET) TRACER FOR TAU 18F-PI-2620 IN INDIVIDUALS WITH DOWN SYNDROME
- Plain-language title
- Imaging Tau in Alzheimer Disease Linked to Down SyndromeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 19 June 2025