Flutemetamol (18F) for Preclinical Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- In order to be eligible to participate in this study, a participant must meet all of the following criteria:  Age 60-100 years  Telephone Interview for Cognitive Status modified (TICS-m) >22 (de Jager, Budge et al. 2003)  Geriatric Depression Scale (GDS) (15 item) <11(Yesavage, Brink et al. 1982)  Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10 word list immediate and delayed recall (> -1.5 SD of age adjusted normative data) (Morris, Heyman et al. 1989)  Clinical Dementia Rating (CDR) scale of 0 with a score on the memory sub domain of 0 (Morris 1993)"}
• {"criterion_text":"- Age 60-100 years"}
• {"criterion_text":"- Telephone Interview for Cognitive Status modified (TICS-m) >22 (de Jager, Budge et al. 2003)"}
• {"criterion_text":"- Geriatric Depression Scale (GDS) (15 item) <11(Yesavage, Brink et al. 1982)"}
• {"criterion_text":"- Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10 word list immediate and delayed recall (> -1.5 SD of age adjusted normative data) (Morris, Heyman et al. 1989)"}
• {"criterion_text":"- Clinical Dementia Rating (CDR) scale of 0 with a score on the memory sub domain of 0 (Morris 1993)"}

Exclusion criteria

• {"criterion_text":"- A potential participant who meets any of the following criteria will be excluded from participation in this study:  Clinical diagnosis of mild cognitive impairment or probable AD  Severe head trauma, with loss of consciousness  Brain tumour (past, present)  Schizophrenia, bipolar disorders, or recurrent psychotic disorders  Stroke resulting in physical impairment  Neurodegenerative disorders (e.g. Huntington disease, cortical basal degeneration, multiple system atrophy, Creutzfeldt-Jacob disease, primary progressive aphasia, Parkinson’s disease)  Epilepsy, currently using antiepileptic drugs (AEDs)  Brain infection (e.g. herpes simplex encephalitis)  Cancer with terminal life expectancy  Known B12 vitamin deficiency without treatment  Uncontrolled diabetes mellitus  Known thyroid disease without treatment  History of recreational drug use  Alcohol consumption: >35 units per week  Physical morbidity or illness which will not permit attendance at visit sessions  Contraindication for MRI (e.g. metal implants, pacemaker etc.)  Medications that may impair cognition, at the discretion of the investigator, e.g.: o High dose benzodiazepine o Lithium carbonate o Antipsychotics including atypical agents o High dose antidepressants o Parkinson’s disease medicines"}
• {"criterion_text":"- Clinical diagnosis of mild cognitive impairment or probable AD"}
• {"criterion_text":"- Severe head trauma, with loss of consciousness"}
• {"criterion_text":"- Brain tumour (past, present)"}
• {"criterion_text":"- Schizophrenia, bipolar disorders, or recurrent psychotic disorders"}
• {"criterion_text":"- Stroke resulting in physical impairment"}
• {"criterion_text":"- Neurodegenerative disorders (e.g. Huntington disease, cortical basal degeneration, multiple system atrophy, Creutzfeldt-Jacob disease, primary progressive aphasia, Parkinson’s disease)"}
• {"criterion_text":"- Epilepsy, currently using antiepileptic drugs (AEDs)"}
• {"criterion_text":"- Brain infection (e.g. herpes simplex encephalitis)"}
• {"criterion_text":"- Cancer with terminal life expectancy"}
• {"criterion_text":"- Known B12 vitamin deficiency without treatment"}
• {"criterion_text":"- Uncontrolled diabetes mellitus"}
• {"criterion_text":"- Known thyroid disease without treatment"}
• {"criterion_text":"- History of recreational drug use"}
• {"criterion_text":"- Alcohol consumption: >35 units per week"}
• {"criterion_text":"- Physical morbidity or illness which will not permit attendance at visit sessions"}
• {"criterion_text":"- Contraindication for MRI (e.g. metal implants, pacemaker etc.)"}
• {"criterion_text":"- Medications that may impair cognition, at the discretion of the investigator"}
• {"criterion_text":"- High dose benzodiazepine"}
• {"criterion_text":"- Lithium carbonate"}
• {"criterion_text":"- Antipsychotics including atypical agents"}
• {"criterion_text":"- High dose antidepressants"}
• {"criterion_text":"- Parkinson’s disease medicines"}

Primary endpoints

• {"endpoint_text":"- 1.To identify clinical markers and biomarkers for amyloid pathology in cognitively normal subjects","definition_or_measurement_approach":"[18F]flutemetamol - PET will be used to measure brain amyloid accumulation; clinical assessments and biomarker analyses as described in objectives."}
• {"endpoint_text":"- 2.To identify risk factors for (change in) amyloid pathology in cognitively normal subjects","definition_or_measurement_approach":"[18F]flutemetamol - PET will be used to measure brain amyloid accumulation; longitudinal assessment of risk factors."}
• {"endpoint_text":"- 3.To identify prognostic markers for cognitive decline in cognitively normal subjects with amyloid pathology","definition_or_measurement_approach":"Identification of prognostic markers using imaging ([18F]flutemetamol PET) and cognitive assessments over time."}

Netherlands

Earliest CTIS Part Ii Submission Date

28-11-2024

Latest Decision Or Authorization Date

29-11-2024

Processing Time Days

1

Number Of Sites

1

Number Of Participants

204

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands