RecruitingNot applicable

Improving Memory in Alzheimer's Disease With Noninvasive Brain Stimulation

Personalized Synchronization of Cortical Rhythms to Improve Memory in Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 100 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests brain stimulation without surgery to learn how brain rhythms may affect memory in Alzheimer's disease. It is for adults ages 50–100 with mild Alzheimer's dementia, milder memory problems due to Alzheimer's, or healthy memory and thinking.

The investigators will evaluate the theory that Alzheimer's disease-related memory impairment derives from the inefficient orchestration of rhythmic activity at the level of large-scale cortical networks. The results as expected to elucidate AD-related pathophysiology and set groundwork for the development of drug-free interventions for improving memory in AD and related dementias.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 50–100 years old.
  • Fit one of three groups: mild Alzheimer's dementia, mild thinking problems due to Alzheimer's, or healthy memory and thinking.
  • For mild Alzheimer's dementia: meet the study's diagnosis rules, score 10–25 on the MoCA thinking test, and have low memory and other thinking test scores.
  • For mild thinking problems due to Alzheimer's: stay independent in daily life, score above 18 on the MoCA, and have low memory test scores.
  • For healthy volunteers: have memory and thinking test results in the study's required range. Volunteers will be matched to Alzheimer's patients by age, education, and gender.
  • Have normal vision, with glasses or contacts if needed, and normal color vision.
  • Be able to understand the consent information and study tasks.

Who can't join

  • Past stroke or brain injury.
  • Another brain or body illness that the study doctor believes has caused lasting thinking problems.
  • Other illnesses or medicines that could strongly affect thinking and rule out the required Alzheimer's diagnosis.
  • Pregnancy.
  • Metal implants in the head or implanted electronic devices.
  • Skin sensitivity.
  • Claustrophobia, or fear of closed spaces.
  • Vision or hearing problems that prevent understanding consent or completing study tasks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

All subjects. Age 50-100 years. We will equally recruit subjects with respect to gender, race, ethnicity, socioeconomic and other factors to allow the results of this research to yield the greatest generalizability. Mild AD dementia. Meets probable AD dementia NIA-AA criteria 86; MoCA 10-25 85; performance on Uniform Data Set version 3 (UDS-3) delayed recall (Craft Story 21) and recognition (Benson Complex Figure) memory worse than 1.5 SD for age and education; worse than 1.5 SD for age and education in at least one other cognitive domain (e.g., language, executive functioning) based on other tests in the UDS-3. A summary of the NIA-AA criteria for AD dementia are that the patient has (1) dementia, such that cognitive or behavioral symptoms (a) are interfering with the ability to function at work or usual activities, (b) represent a decline from previous level of functioning, (c) are not explained by delirium or major psychiatric disorder, (d) are detected and diagnosed, and (e) involve a minimum of two domains including memory, executive function, visuospatial abilities, language, and personality or behavior or comportment; (2) insidious onset; (3) clear-cut history of worsening of cognition; (4) prominent cognitive deficits by history and examination from either (a) an amnestic presentation or (b) a non-amnestic presentation, which can be a language, visuospatial, or executive dysfunction presentation; and lastly (5) no (a) substantial concomitant cerebrovascular disease, (b) core features of Dementia with Lewy Bodies, (c) prominent features of behavioral variant frontotemporal dementia (FTD), (d) prominent features of primary progressive aphasia, or (e) evidence for another concurrent, active disorder or use of medication that could have a substantial effect on cognition. All diagnoses are made by the BU ADRC clinical core consensus and confirmed by Dr. Budson. The majority of patients will have a positive AD biomarker, either from cerebrospinal fluid (CSF) or positron emission tomography (PET). See also Additional Inclusion/Exclusion criteria below. MCI due to AD. Meets MCI due to AD according to NIA-AA criteria 86; MoCA \>18 85; performance on Uniform Data Set version 3 (UDS-3) delayed recall (Craft Story 21) and recognition (Benson Complex Figure) memory worse than 1.0 SD for age and education adjusted norms. A summary of the NIA-AA criteria for MCI due to AD are that there is (1) clinical concern reflecting a change in cognition reported by patient, informant, or clinician; (2) objective impairment in one or more domains, typically including memory; (3) preservation of independence in functional abilities; (4) not demented; (5) a rule out of vascular, traumatic, and medical causes of cognitive decline; (6) evidence of longitudinal decline in cognition, when feasible; (7) history consistent with AD genetic factors, where relevant. All diagnoses are made by the BU ADRC clinical core consensus and confirmed by Dr. Budson. The majority of patients will have a positive AD biomarker, either from CSF or PET. See also Additional Inclusion/Exclusion criteria below. Healthy controls. Healthy controls will also be recruited from the BU ADRC and will be age, education, and gender matched to the AD patients. They will have a MoCA \> 2585 and performance within 1.0 SD for age and education adjusted norms on Uniform Data Set version 3 (UDS-3). All "diagnoses" of healthy controls will be made by the BU ADRC clinical core consensus and confirmed by Dr. Budson. The majority of healthy controls will have a negative AD biomarker, either from CSF or PET. See also Additional Inclusion/Exclusion criteria below. All subjects. Current conditions allowed: mild depression and/or anxiety not requiring hospitalization or medications other than what are listed below; hyperlipidemia; hypercholesterolemia; hypertension; heart disease; asthma; gastroesophageal reflux disease; edema; treated hypothyroidism; systemic vascular disease (but not stroke); dermatological disorders; ophthalmologic disorders. Prior conditions excluded: stroke, traumatic brain injury, other brain or systemic disorder that, in the opinion of Dr. Budson, has produced a permanent alteration of cognition. Current medications allowed: selective serotonin reuptake inhibitors; cholinesterase inhibitors (for the patients with AD); statins; beta adrenergic blockers; bronchodilators; ace inhibitors; calcium channel blockers; angiotensin II receptor blockers; other antihypertensive agents; histamine-2 receptor antagonists; proton-pump inhibitors; diuretics; thyroid medications; aspirin; non-narcotic analgesics; antiplatelet agents; vitamins \& minerals; topical medications; eye drops. Inclusion/exclusion criteria related to tasks, EEG and tACS. Subjects must have normal or corrected-to-normal vision, color vision, nonpregnant, no metal implants in head, no implanted electronic devices, no skin sensitivity, and no claustrophobia. Additional exclusion criteria. Subjects will be excluded if they cannot understand the informed consent or the experimental procedures. Subjects will be excluded if they have a significant vision and/or hearing impairment which will prevent them from understanding the informed consent and from completing the experimental procedures.

Study sites (1)

MA