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Summary

for people ages 55–90 (full criteria)
healthy people welcome
study started
estimated completion:

Description

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™ neuromotor 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.

Official Title

Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (Altoida™) as a Useful Neuromotor Biomarker for Alzheimer's Disease

Details

The goal of the study is to determine relationships among the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the stage of the AD spectrum that precedes MCI, the mildest symptomatic phase of AD, referred to here as EMCI. The ADNI-GO model posits that AD begins with amyloid β (Aβ) deposition in the cortex, which leads to synaptic dysfunction, neurodegeneration, and cognitive/ functional decline.

Some of the leading-edge technologies under study are brain-imaging techniques, such as positron emission tomography (PET), including FDG-PET (which measures glucose metabolism in the brain); PET using a radioactive compound (F-AV-45) that measures brain beta-amyloid; and structural MRI. Brain scans are showing scientists how the brain's structure and function change as AD starts and progresses. Biomarkers in cerebrospinal fluid are revealing other changes that could identify which patients with MCI will develop Alzheimer's. Scientists are looking at levels of beta-amyloid and tau in cerebrospinal fluid. (Abnormal amounts of the amyloid and tau proteins in the brain are hallmarks of Alzheimer's disease.)

The aim of the study is to evaluate the performance of the ALTOIDA™ System as as a tool to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings.

The study will be :

A. Multi-Center Study:

primary goal of this study will be to evaluate the ALTOIDA™ Platform across multiple study locations. This will demonstrate an ability to perform tests, collect data, and generate classifications irrespective of variations in testing locations and personnel.

7-8 study sites will be selected with each site being a recognized NIH Center of Excellence for Alzheimer's disease or other nationally recognized Alzheimer's disease research center.

Each site will evaluate up to 60 subjects evenly divided between AD patients and age-matched controls (while the prevalence of AD is approximately 12% in the general population, the ratio of AD to normal among those who visit a clinic for memory or cognitive related issues is between 50-60%).

Each site will follow the same testing protocols. All test data will be uploaded to the online ALTOIDA™ database server.

B. The overall impact of this study will be increased knowledge concerning the sequence and timing of events leading to MCI and AD, development of better clinical and neuromotor biomarker methods for early detection and for monitoring the progression of these conditions, and facilitation of clinical trials of treatments to slow disease progression, ultimately contributing to the prevention of AD.

Keywords

Alzheimer Disease Mild Cognitive Impairment Memory Disorders Cognitive Impairment Dementia biomarkers CSF EEG MRI

Eligibility

You can join if…

Open to people ages 55–90

  • Between 55 and 90 years of age
  • Study partner to accompany patient to all clinic visits for the duration of the protocol
  • Memory complaint by patient and/or study partner
  • Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
  • Mini-Mental State Exam score between 24 and 30 (inclusive)
  • Clinical Dementia Rating = 0.5; Memory Box score at least 0.5
  • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit
  • Stability of the following permitted medications for 4 weeks (unless stated otherwise):
  • Antidepressants lacking significant anticholinergic side effects
  • Estrogen replacement therapy
  • Gingko biloba is permissible, but discouraged
  • Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics,chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
  • Cholinesterase inhibitors and memantine if stable for 12 weeks prior to screening
  • Geriatric Depression Scale less than 6
  • Visual and auditory acuity adequate for neuropsychological testing
  • Good general health with no diseases expected to interfere with the study
  • Not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile)
  • Hachinski less than or equal to 4
  • Six grade education or has a good work history (sufficient to exclude mental retardation)
  • Fluent in English or Spanish
  • Agrees to at least one lumbar puncture for the collection of CSF
  • Willing and able to complete all baseline assessments
  • Willing to undergo repeated MRIs and at least two PET scans and willing to provide DNA and plasma samples as specified
  • Willing and able to participate in a longitudinal imaging study

You CAN'T join if...

  • Any significant neurologic disease other than suspected incipient Alzheimer's disease,such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder,subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
  • Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions; multiple lacunes or lacunes in a critical memory structure
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
  • Major depression, bipolar disorder as described in DSM-IV within the past 1 year
  • Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol
  • History of schizophrenia
  • History of alcohol or substance abuse or dependence within the past 2 years
  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
  • Clinically significant abnormalities in B12, or TFTs that might interfere with the study
  • Residence in skilled nursing facility
  • Current use of specific psychoactive medications (e.g.,certain antidepressants,neuroleptics, chronic anxiolytics or sedative hypnotics, etc.); current use of warfarin (exclusionary for lumbar puncture)
  • Use of investigational agents one month prior to entry and for the duration of the trial
  • Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1
  • Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Altoida
Links
Five-year biomarker progression variability for Alzheimer's disease dementia prediction: Can a complex instrumental activities of daily living marker fill in the gaps?
ID
NCT02843529
Study Type
Interventional
Last Updated
May 1, 2017