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Device
Deep Brain Stimulation for Alzheimer's Disease
N/A
Waitlist Available
Led By Andres Lozano, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, baseline, post-operative months 1, 3, 6, 9, 12
Awards & highlights
Study Summary
This trial will study the effect of deep brain stimulation (DBS) on cerebrospinal fluid (CSF) and brain amyloid pathology in Alzheimer's Disease (AD). Twelve patients will be recruited and undergo DBS implantation surgery followed by neuropsychological testing and assessment for 12 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, baseline, post-operative months 1, 3, 6, 9, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, baseline, post-operative months 1, 3, 6, 9, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Change in Cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease
Change in Clinical Dementia Rating (CDR) Scale
+2 moreSecondary outcome measures
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory 23-item Scale (ADCS-ADL23)
Hopkins Verbal Learning Test (HVLT)
Visual Association Memory Test
Other outcome measures
Columbia Suicide Severity Rating Scale (C-SSRS)
Cornell Scale for Depression in Dementia (CSDD)
Personality inventories
+1 moreSide effects data
From 2018 Phase 2 trial • 53 Patients • NCT0122194823%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Head injury
5%
Dyspepsia
5%
Back pain
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Pain in extremity
3%
Diabetes mellitus
3%
Intervertebral disc protrusion
3%
Spinal osteoarthritis
3%
Fluid retention
3%
Postoperative wound infection
3%
Osteoarthritis
3%
Macular degeneration
3%
Hypoaesthesia
3%
Productive cough
3%
Ingrowing nail
3%
Respiratory depression
3%
Parkinson's disease
3%
Device migration
3%
Akinesia
3%
Syncope
3%
Diplopia
3%
Skin laceration
3%
Joint sprain
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All patients will be implanted with a deep brain stimulation system and will receive personalized fornix stimulation; parameters will be selected based on the dose finding cognitive tests.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,508 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,256 Previous Clinical Trials
14,820,060 Total Patients Enrolled
Andres Lozano, MD, PhDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
92 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have significant neuropsychiatric symptoms or apathy.If the doctor or the patient thinks there is a risk of suicide, or if the patient answers 'yes' to certain questions about thinking about suicide on a questionnaire.Your score on the Young Mania Rating Scale is 11 or higher during the screening visit.Intellectual disabilityYour memory and thinking test scores fall within certain ranges.You are expected to live less than one year.You are between 45 and 85 years old.You have signs and symptoms that suggest you may have Alzheimer's disease according to specific criteria set by a recognized association.You have been diagnosed with mild cognitive impairment or very mild dementia.You have had a head injury in the 2 years before joining the study.The doctor thinks that you might be at risk of hurting yourself during the study.You have a current problem with drinking alcohol or using drugs, as defined by a specific guide for mental disorders.You cannot have a PET scan if you have insulin-dependent diabetes.Your score on the Cornell Scale for Depression and Dementia (CSDD) is higher than 10 during the screening visit.You have had a brain tumor, significant bleeding in the brain, or other large abnormal growth in the brain as seen on scans.You have a current mental health condition that needs treatment.You are in good or excellent overall health.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research initiative welcome individuals who are over four decades of age?
"The parameters for enrollment in this medical trial mandate that the age of participants is between 45 and 85. This research has 23 studies involving individuals under 18 years old, as well as 538 trials centred around those older than 65."
Answered by AI
Is it possible to join this scientific experiment?
"Admission to this trial requires a primary diagnosis of Alzheimer's and an age range between 45 and 85. Around 12 people are expected to join the experiment."
Answered by AI
Are there any unoccupied roles in this experiment for participants?
"According to the information hosted on clinicaltrials.gov, this particular medical trial is no longer accepting new patients. The initial posting was made in December of 2014 and the most recent revision was from May 16th 2022. However, there are 548 different trials that are still actively recruiting participants at present."
Answered by AI
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