Alzheimer DiseaseNCT00658125
Deep Brain Stimulation (DBS) for Alzheimer's Disease
A study testing Bilateral fornix DBS implantation, in people with Alzheimer Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Bilateral fornix DBS implantation,
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2007to 30 Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 40 to 80 years old, who
- Satisfy the diagnostic criteria for probable AD,
- Have received the diagnosis of AD within the past 2 years,
- Have a CDR of 0.5 or 1.0, and
- Score between 20 and 28 on the Mini Mental State Examination
Who cannot join
- Pre-existing structural brain abnormalities,
- Other neurologic or psychiatric diagnoses, or
- Medical comorbidities that would preclude them from undergoing surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease
Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human.
Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain.
Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.
- Conditions
- Alzheimer Disease
- Being tested
- Bilateral fornix DBS implantation,
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral fornix DBS implantation,Procedure or surgery
Also called DBS
Fornix DBS for Alzheimer Disease
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Procedure: Bilateral fornix DBS implantation, |
What is being measured
The primary outcome is the main question the study is designed to answer.
memory performance on neuropsychological tests
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study start1 Mar 2007
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Lozano, University Health Network, Toronto
- Investigators
- Adrian W Laxton, MD, Study director, Toronto Western Research InstituteAndres M Lozano, MD, PhD, Principal investigator, Toronto Western Research InstituteDavid Tang-Wai, MD, Principal investigator, Toronto Western Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658125
- Sponsor's protocol ID
- 06-0095-B
- Status last verified
- Sep 2019
- First submitted
- 9 Apr 2008
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hamani C, McAndrews MP, Cohn M, Oh M, Zumsteg D, Shapiro CM, Wennberg RA, Lozano AM. Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Ann Neurol. 2008 Jan;63(1):119-23. doi: 10.1002/ana.21295.
PubMed 18232017
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease
- ClinicalTrials.gov ID
- NCT00658125
- Acronym / sponsor ID
- 06-0095-B
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human.
Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain.
Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Bilateral fornix DBS implantation, |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 40 to 80 years old, who
- Satisfy the diagnostic criteria for probable AD,
- Have received the diagnosis of AD within the past 2 years,
- Have a CDR of 0.5 or 1.0, and
- Score between 20 and 28 on the Mini Mental State Examination
Key exclusion criteria (3 listed)
- Pre-existing structural brain abnormalities,
- Other neurologic or psychiatric diagnoses, or
- Medical comorbidities that would preclude them from undergoing surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral fornix DBS implantation,Also: DBSFornix DBS for Alzheimer Disease | Procedure or surgery | Experimental |
Primary outcome
memory performance on neuropsychological tests
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Background: PubMed 18232017Hamani C, McAndrews MP, Cohn M, Oh M, Zumsteg D, Shapiro CM, Wennberg RA, Lozano AM. Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Ann Neurol. 2008 Jan;63(1):119-23. doi: 10.1002/ana.21295.
Related trials for Alzheimer Disease
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease
Transcranial Alternating Current Stimulation, Alzheimer Disease (AD)
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian W Laxton, MD study director
Toronto Western Research Institute
Andres M Lozano, MD, PhD principal investigator
Toronto Western Research Institute
David Tang-Wai, MD principal investigator
Toronto Western Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral fornix DBS implantation, in people with Alzheimer Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
memory performance on neuropsychological tests (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00658125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.