Stimulating Neural Activity to Improve Blood Flow and Reduce Amyloid: Path to Clinical Trials

Completed · Not applicable

Conditions studied: Alzheimer Disease

In brief

Alzheimer's disease is characterized by the accumulation of toxic proteins in the brain. Mechanisms to remove these proteins have been the target of many drug trials. This study is designed to use a device to entrain brain waves to a specific frequency to see if rodent research can be replicated in humans with mild cognitive impairment. Ten participants will be recruited from the Emory Alzheimer's Disease Research Center (ADRC) database and assigned to either treatment for 8 weeks or treatment for 4 weeks. This latter group will serve as the control group (4 weeks no treatment, 4 weeks treatment). It is hypothesized that exposure to the gamma oscillations (Flicker) will clear toxic proteins from the brain and increase cerebral blood flow.

Key facts

Study ID: NCT03543878
Run by: Emory University
People needed: 10
Starts: 2018-11-16
Expected to finish: 2020-02-10
Last updated by the study team: 2021-03-02

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must have a subjective memory concern as reported by subject, study partner or clinician.
Meets local criteria for diagnosis of mild cognitive impairment (MCI).
Montreal Cognitive Assessment (MoCA) score >15. Exceptions may be made for subjects with less than 8 years of education at the discretion of the PI.
Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5.
General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's Disease (AD) cannot be made by the physician at the time of the screening visit.
Stable on medications for 4 weeks prior to initiation of study sessions.
Geriatric Depression Scale (GDS) ≤ than 6.
Male or female outpatients aged 50-90 (inclusive).
Able to hear without the use of hearing aids.
Study partner who lives with the participant and can provide a reliable assessment of the participant's level of function, is available for all clinic visits, and can serve as a supervisor/monitor for the home-based Flicker sessions for the duration of the study.
Visual and auditory acuity adequate for neuropsychological testing.
Good general health with no diseases expected to interfere with the study.
Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
Able to communicate in English with study personnel.
Able to understand the nature of the study and provision of written informed consent prior to conduct of any study procedures.
Willing to undergo repeated magnetic resonance imaging (MRI) and positron emission tomography (PET) scans.
Agrees to blood collection for apolipoprotein E (ApoE) and biomarker testing.
Agrees to lumbar puncture over the course of the study for the collection of cerebrospinal fluid (CSF).

You may not qualify if…

Any significant neurologic disease other than MCI and suspected incipient AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, poorly controlled seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
Screening/baseline MRI scan with evidence of infection, large vessel infarction or other focal structural lesions that could account for the memory deficits. Subjects with multiple lacunes or lacunes in a critical memory structure are excluded.
Contraindication to MRI due to pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, or excessive weight.
Presence of clinically significant suicide risk, based on the Investigator's judgment informed by a structured clinician interview. Any suicide attempt within the past 1 year of the screening visit is exclusionary.
Major depression, bipolar disorder as described in Diagnostic and Statistical Manual of Mental Disorders-4 (DSM-IV) within the past 1 year, or history of schizophrenia.
Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria).
Known history of epilepsy or migraines, which may be exacerbated by study intervention.
History of narrow angle (acute angle) glaucoma.
Current use of warfarin or other blood thinners (exclusionary for lumbar puncture).
Inability to obtain initial CSF sample.
Current use of Namenda (memantine).
Current use of medications that lower seizure threshold, including Wellbutrin, Ciprofloxacin, Levofloxacin, Seroquel, Phenergan, and Sumatriptan.
Current use of anti-psychotic medication.
CSF profile inconsistent with underlying Alzheimer's Disease pathology.
Reasonable likelihood for non-compliance with the protocol or any other reason, in the opinion of the investigator, prohibits enrollment of subject into the study.
Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director.

Where it is running

12 Executive Park Drive — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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