Overview
Sponsor-declared trial summary
Down Syndrome
• 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.
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 3 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515574-27-00
- EudraCT number
- 2019-004634-41
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Diagnosis
• 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.
Conditions and MedDRA coding
Down Syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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.
Exclusion criteria 4
- 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.
- Severe depression (Geriatric Depression Scale score > 20)
- History of stroke, Hachinski score > 4, or previous neurological or psychiatric illness.
- Confirmed pregnancy or possibility of pregnancy at the time of study inclusion.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The primary efficacy variable of the study, at both measurement time points, will be the Standardized Uptake Value Ratio (SUVR) from images generated with 18F-PI-2620 (images will be obtained between 0-90 minutes post-administration; the cerebellum will be used as the reference region), as a measure of tau protein aggregates in the brain.
- In addition to efficacy data, adverse effects will be recorded during the 24 hours following administration.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8361304 · Product
- Active substance
- Izaflortaucipir (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 185 MBq megabecquerel(s)
- Max total dose
- 185 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- LIFE MOLECULAR IMAGING GMBH
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- UICEC Sant Pau
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-07-03 | 2024-07-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2019-004634-41_for pub | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PUB 2019-004634-41 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2019-004634-41 for pub | 4 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-18 | Spain | Acceptable 2024-07-03
|
2024-07-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-06 | Spain | Acceptable 2025-06-19
|
2025-06-19 |