Mild cognitive impairment
Conditions
Interventions
Trade Name: NeuraCeq
Product Name: Neuraceq
Pharmaceutical Form: Solution for injection/infusion
Sponsors
University of Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female and between = 55 and = 85 years of age on the day of signing the consent form. 2. If female, patient is not of reproductive potential (two years post-menopausal or surgically sterile). 4. Patient has a subjective memory concern as reported by subject, study partner, or clinician. 5. Patient has an abnormal memory function documented by scoring within the education adjusted ranges on the CANTAB memory performance (= -1SD). 6. Patient has a Global Clinical Dementia Rating score of 0 or 0.5. 7. In the opinion of the investigator, the patient is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator. 8. Patient has at least six years of education, or work history sufficient, in the investigator’s opinion, to exclude mental retardation. 9. Patient is fluent in written and verbal Dutch. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Patient has a history or current evidence of a neurological disorder, that in the opinion of the primary investigator may contribute to the subject's cognitive impairment, including, but not limited to: ? Large-vessel stroke, ? epilepsy, ? Parkinson’s disease, ? progressive supranuclear palsy, ? Huntington’s disease, ? amyotrophic lateral sclerosis, ? multiple sclerosis, ? CNS infection, ? significant head trauma with loss of consciousness, ? Normal pressure hydrocephalus 2. Patient has a history of large-vessel stroke or evidence of a large-vessel infarction or other focal lesions on baseline MRI scan that may contribute to the cause of the memory impairment in the opinion of the investigator. Vascular white matter lesions or other signs of microangiopathy will not be considered an exclusion. 3. Patient has a history within 6 months prior to screening visit or current evidence of a psychotic disorder or a major untreated depressive disorder. 4. Patient has a history of malignancy =5 years prior to signing informed consent, except for patients who have undergone potentially curative therapy with no evidence of recurrence for 1 year, and who are deemed at low risk for recurrence by her/his treating physician. 5. Patient has a history or current evidence of any potentially known clinically significant condition , therapy, lab abnormality or other circumstance that in the opinion of the investigator might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate. 6. Patients currently use specific psychoactive medications (neuroleptics, chronic anxiolytics, tricyclic antidepressants, antiepileptics, anticholinergics etc.). Stable dose trazodone, mirtazapine or low dose benzodiazepines prescribed for mild insomnia is allowed. 7. Patients currently use antithrombotics with the exception of acetyl salicylic acid (exclusionary for lumbar puncture). 8. Cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen. 9. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria) 10. Patient is currently participating or has participated in a study with an investigational compound or neuropsychological measures within 30 days of signing informed consent. 11. Subject has any magnetizable metal prostheses, implants or foreign objects that could pose a hazard during MRI scans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will test the predictive value of baseline flutemetamol capture for longitudinal change in amyloid load measured using PET in MCI cases. Second, we will compare CSF Aß42 and amyloid PET for classification of amyloid-positive and amyloid negative cases. Third, we will compare the predictive value of CSF AD biomarkers Aß42, T-tau and P-tau181P with that of amyloid imaging for MCI cases that progress to Alzheimer's disease.;Secondary Objective: Our secondary objectives include the evaluation of whether a change in amyloid deposition (measured by CSF Aß42 or SUVR) over a 1 year period predicts cognitive decline over a 2 year time period and whether both measures contribute independently to this decline. Further, we will analyze the predictive value of classical AD biomarkers changes after one year on the progression of cognitive change after 2 years. We will also explore the correlation of baseline exploratory candidate biomarkers.;Primary end point(s): Since this study is not interventional, no end points are defined.;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactMemory Clinic
University of Leuven
Outcome results
None listed