Alzheimer DiseaseNCT05925621
Cognitive Neurology Unit Clinical Registry
An observational study of Alzheimer Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Lecanemab
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2023to Jun 2028
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll patients under the care of the CNU. All patients with a concern for cognitive impairment secondary to AD interested in receiving anti-amyloid monoclonal antibody therapy will be enrolled into this registry as required by CMS. * Patients with a diagnosis of AD based on National Institute on Aging and the Alzheimer's Association diagnostic guidelines. * Patients with a diagnosis of MCI based on the National Institute on Aging and the Alzheimer's Association and Petersen criteria. * All patients eligible to receive anti-amyloid therapy will have confirmation of AD through a positive amyloid PET.
Who may be able to join
- o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease
- Patient has evidence of cognitive impairment on neuropsychological testing
- Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement
- Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease
- Amyloid PET imaging positive
- CSF p-Tau/Abeta42 ration >0.023 and ABeta42 < 1027**
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- 3T MRI in past 6 months
- Patient has a care partner
- Patient under the care of an appropriate BI-Lahey amyloid clinic
- Patient is on a stable medication regimen
Who cannot join
- o Recent stroke or suspected TIA in the past year
- Pregnancy
- Active autoimmune or immunological disease
- Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives
- Bleeding disorder with Plts < 50,000 or INR > 1.5
- On warfarin, heparin, or DOAC
Show all 9Show fewer
- On dual antiplatelet therapy
- Non Alzheimer disease cause of dementia/MCI
- ApoE e4 homozygote
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Read the detailed description
Alzheimer's disease (AD) is a neurodegenerative disorder associated with brain deposition of extracellular amyloid and intracellular tau. It causes progressive cognitive impairment, especially memory, and is invariably fatal. Currently, there is no effective treatment for AD. A new and promising method involves the use of anti-amyloid-beta monoclonal antibodies (anti-amyloid mAbs) to reduce amyloid accumulation in brain. There are currently two anti-amyloid mABs, aducanumab and lecanemab, approved by the FDA under FDA's "accelerated approval" pathway. However, so far there is only a single phase 3 study that unequivocally demonstrates clinical efficacy of anti-amyloid mAB therapy1. This study is designed to help determine the therapeutic benefit of anti-amyloid mABs therapy by treating AD patients in our clinic with anti-amyloid mABs and measuring cognitive impairment and functional outcomes over the course of the treatment period and beyond. This study has 4 specific aims.
SPECIFIC AIM 1: TO CREATE A CNU ANTI-AMYLOID MONOCLONAL ANTIBODY REGISTRY
SPECIFIC AIM 2: TO DETERMINE WHETHER ANTI-AMYLOID MABs SLOW COGNITIVE AND FUNCTIONAL DECLINE
SPECIFIC AIM 3: TO IDENTIFY ANY ASSOCIATIONS BETWEEN SIDES EFFECTS AND PATIENT CHARACTERISTICS
SPECIFIC AIM 4: TO ESTABLISH THE TIME COURSE OF CLINICAL BENEFITS
- Conditions
- Alzheimer Disease
- Being tested
- Lecanemab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LecanemabDrug
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Lecanemab | Patients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC Receives: Drug: Lecanemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline
This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms.
Measured: 30 months
To Identify Any Associations Between Side Effects And Patient Characteristics
This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes.
Measured: 30 months
To Establish The Time Course Of Clinical Benefits
This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start16 Jul 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Press, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925621
- Sponsor's protocol ID
- 2023P000494
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets may be shared with members outside the study team following de-identification under approved data use agreements (DUAs) as needed. Within the REDcap database, access to the identifiable information will be limited to study staff members and to staff managing the database. Any data that may require a physical transfer from one place to another will be done using removable encrypted data storage devices.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry
- ClinicalTrials.gov ID
- NCT05925621
- Acronym / sponsor ID
- 2023P000494
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 16 Jul 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Jun 2023 (actual)
- 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.
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Detailed description
Alzheimer's disease (AD) is a neurodegenerative disorder associated with brain deposition of extracellular amyloid and intracellular tau. It causes progressive cognitive impairment, especially memory, and is invariably fatal. Currently, there is no effective treatment for AD. A new and promising method involves the use of anti-amyloid-beta monoclonal antibodies (anti-amyloid mAbs) to reduce amyloid accumulation in brain. There are currently two anti-amyloid mABs, aducanumab and lecanemab, approved by the FDA under FDA's "accelerated approval" pathway. However, so far there is only a single phase 3 study that unequivocally demonstrates clinical efficacy of anti-amyloid mAB therapy1. This study is designed to help determine the therapeutic benefit of anti-amyloid mABs therapy by treating AD patients in our clinic with anti-amyloid mABs and measuring cognitive impairment and functional outcomes over the course of the treatment period and beyond. This study has 4 specific aims.
SPECIFIC AIM 1: TO CREATE A CNU ANTI-AMYLOID MONOCLONAL ANTIBODY REGISTRY
SPECIFIC AIM 2: TO DETERMINE WHETHER ANTI-AMYLOID MABs SLOW COGNITIVE AND FUNCTIONAL DECLINE
SPECIFIC AIM 3: TO IDENTIFY ANY ASSOCIATIONS BETWEEN SIDES EFFECTS AND PATIENT CHARACTERISTICS
SPECIFIC AIM 4: TO ESTABLISH THE TIME COURSE OF CLINICAL BENEFITS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lecanemab | – | Drug: LecanemabPatients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll patients under the care of the CNU. All patients with a concern for cognitive impairment secondary to AD interested in receiving anti-amyloid monoclonal antibody therapy will be enrolled into this registry as required by CMS. * Patients with a diagnosis of AD based on National Institute on Aging and the Alzheimer's Association diagnostic guidelines. * Patients with a diagnosis of MCI based on the National Institute on Aging and the Alzheimer's Association and Petersen criteria. * All patients eligible to receive anti-amyloid therapy will have confirmation of AD through a positive amyloid PET.
Key inclusion criteria (10 listed)
- o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease
Key exclusion criteria (9 listed)
- o Recent stroke or suspected TIA in the past year
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 |
|---|---|---|
| LecanemabObservational study | Drug | Lecanemab |
Primary outcome
To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline
Time frame: 30 months
This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms.
To Identify Any Associations Between Side Effects And Patient Characteristics
Time frame: 30 months
This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes.
To Establish The Time Course Of Clinical Benefits
Time frame: 30 months
This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Data sets may be shared with members outside the study team following de-identification under approved data use agreements (DUAs) as needed. Within the REDcap database, access to the identifiable information will be limited to study staff members and to staff managing the database. Any data that may require a physical transfer from one place to another will be done using removable encrypted data storage devices.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Z Press, MD ((617) 667-4074, dpress@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline (time frame: 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.