Alzheimer Disease
Conditions
Brief summary
This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.
Detailed description
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD
Interventions
Subjects will undergo undergo a single LIFU of the target brain region
Sponsors
Ali Rezai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant females, aged 45-85 years * Able and willing to give informed consent * Must meet the clinical criteria for MCI due to Alzheimer's disease * If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days * Able to communicate sensations during the LIFU procedure
Exclusion criteria
* Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia). * Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain. * Participants with a history of seizure disorder. * Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area. * Participant does not speak English * Participant is pregnant or planning to be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events | baseline and 7 and days after study procedure | Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence. |
| Cognitive Change | baseline and 7 days after procedure | Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging Changes | baseline, 7 and 30 days | Changes in brain metabolism and connectivity using PET and fMRI |
Countries
United States
Contacts
Primary ContactMarc Haut, PhD
Outcome results
None listed