DBS for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 65+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Functional Neuromodulation Ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?The primary efficacy objective of this study is to test the hypothesis that DBS-f stimulation (ON) will slow cognitive and functional progression of AD, as compared to no stimulation (OFF), by measuring baseline (pre-implantation) to 12-month change in the integrated Alzheimer's disease rating scale (iADRS).

Eligibility Criteria

This trial is for individuals at least 65 years old with mild Alzheimer's Disease, confirmed by specific criteria and CSF biomarkers. Participants must be fluent in the test language, have a caregiver, and either take stable Alzheimer's medication or have documented reasons not to. They should be good candidates for deep brain stimulator surgery but can't join if they have certain cardiovascular issues, psychiatric disorders, high stroke risk scores, or are involved in other clinical trials.

Inclusion Criteria

I am 65 years old or older.

My memory test score is between 10 and 24, showing some memory issues.

I have been diagnosed with Alzheimer's disease.

My memory test score is between 10 and 24, showing some memory issues.

Exclusion Criteria

I haven't been exposed to high levels of radiation in the last year.

I am not currently using, nor plan to use, any amyloid-beta drugs like aducanumab within a year after joining this study.

I have a history of seizures.

Participant Groups

The ADvance II Study is testing whether turning on deep brain stimulation (DBS-f) slows down cognitive decline in Alzheimer's patients compared to no stimulation. The effect of DBS-f will be measured over a year using an integrated rating scale that assesses both cognitive and functional abilities.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DBS OnExperimental Treatment1 Intervention

DBS system On

Group II: DBS OffPlacebo Group1 Intervention

DBS System Off