Alzheimer disease
Conditions
Interventions
Trade Name: FARNA FDG 3000 MBq/ml solución inyectable
Product Name: fludesoxiglucosa
Pharmaceutical Form: Solution for injection
INN or Proposed INN: fl
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signature of informed consent by the participant and companion of the study before carrying out any procedure related to the study 2. Age = 18 years and the child of an individual affected (clinically or by tests) of genetic Alzheimer's disease in a pedigree with a known mutation causing genetic Alzheimer's disease. 3. Cognitively normal (Clinical dementia Rating scale, CDR = 0) or with cognitive impairment in mild phase (CDR 0.5 or 1). 4. The participant has identified two people who are not their blood siblings who can serve as companions to the study. 5. Sufficient knowledge of the Castilian language (equivalent to 6th grade of primary school). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. The participant has a medical or psychiatric illness that would interfere according to clinical criteria in the initial evaluation and / or follow-up evaluations. 2. The participant has an advanced cognitive impairment that requires admission to a long-term care center. 3. The recruitment of a subject with cognitive impairment must be pre-approved by the Coordinating Group of DIAN. 4. Women who are pregnant or breast-feeding or who have planned to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the safety profile after a dose of FDG and GDP for the realization of PET in individuals with genetic risk of autosomal dominant Alzheimer's disease. 2. To determine the frequency, extent and severity of alterations in PET patterns with FDG and PIB, MR parameters, biochemical and cognitive markers in subjects carrying mutations causing genetic Alzheimer's disease with respect to their non-carrier pairs. ; Secondary Objective: 1. Participate in the DIAN international multicentre registry of biological adult children of a parent affected by an APP, PSEN1 or PSEN2 mutation causing autosomal dominant Alzheimer's disease and evaluate the participants with a standardized protocol (DIAN) biannually. 2. Contribute to the collection of data as well as participate in the repository of biological samples to promote research in autosomal dominant Alzheimer's and analysis in several domains. 3. Identify new diagnostic and prognostic biomarkers. ;Timepoint(s) of evaluation of this end point: At any time during the follow-up (up to 36 months); Primary end point(s): 1. Incidence of adverse events after administration of a dose of [18F] FDG and [11C] PIB in individuals at risk of genetic Alzheimer's disease. 2. Proportion of carriers of mutations causing genetic Alzheimer's disease that present alterations in FDG-PET, PIB-PET, MRI and in biochemical markers with respect to non-carrier pairs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Relative age at which each marker begins to show pathological values in mutation carriers with respect to non-carrier pairs. 2. Magnitude of longitudinal change in each of the biomarkers studied. ;Timepoint(s) of evaluation of this end point: At any time during the follow-up (up to 36 months) | — |
Countries
Spain
Contacts
Public ContactJoan Albert Arnaiz
CTU CLINIC
Outcome results
None listed