At a glance
ClinicalIndex Comparison Record- ✓Age 55–90 years
- ✓Memory complaint documented by patient and/or study partner
- ✓Abnormal memory function on Wechsler Memory Scale adjusted for education
- ✓Mini-Mental State Exam score 24–30 inclusive
- ✕Significant neurologic disease other than suspected incipient Alzheimer's disease (e.g., Parkinson's, multi-infarct dementia, Huntington's, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or significant head trauma with persistent neurologic deficits)
- ✕MRI evidence of infection, infarction, focal lesions, multiple lacunes, or lacunes in critical memory structures
- ✕Contraindications to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in eyes, skin, or body)
- ✕Major depression or bipolar disorder within past 1 year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) as a Pre-Clinical or Pro-Dromal Alzheimers Diagnosis (Prognosis) for Optimum Outcomes
In Brief
A clinical study evaluating Altoida: neuropsychological, MRI, EEG and CSF biomarkers for Alzheimer Disease and 5 related conditions. Completed, enrolled 548 participants.
Detailed Summary
The proposed study is designed to evaluate the performance of the ALTOIDA™ System as a tool to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings. The design of this study is guided by two overriding factors: 1) to optimize the performance of the ALTOIDA™ Neuro Motor Index (NMI) prognosis classifiers, the subjects making up the training sets must be well characterized as to their clinical diagnosis, and 2) all ALTOIDA™ tests must be performed and reproduced in real-world clinical settings. Although there is already a large body of peer-reviewed scientific literature demonstrating that certain digital biomarker patterns are associated with certain neurologic conditions, the utilization of such tools for the evaluation of neurologic disorders is still considered an emerging science and therefore in the investigational stage. Although this protocol will report on brain patterns of certain neurologic conditions such as cognitive impairment and Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are not considered stand alone or diagnostic per se and should always be considered by the primary physician in conjunction with the patient's clinical condition. These data should only be used as additional information to add to the primary physician's diagnostic impression.
Study Details
Timeline
Interventions
Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects.