DIAD CLINIC

Cognitive Neurology Unit’s Disease Modifying Immunotherapies for the treatment of Alzheimer’s Disease (DiAD) clinic

BIDMC ANTI-AMLOID ENROLLMENT

We schedule patients in our DiAD clinic exclusively through this enrollment list.

ANTI-AMYLOID MONOCLONAL ANTIBODY INFORMATION

LECANEMAB HAS BEEN FDA APPROVED FOR THE TREATMENT OF ALZHEIMER’S DISEASE

On July 6th, 2023, the FDA announced traditional approval for the anti-amyloid monoclonal antibody therapy, lecanemab, for treatment of Alzheimer’s disease.

FDA ANNOUNCEMENT

The Center for Medicare and Medicaid Services (CMS) also announced that monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease that receive traditional approval from the FDA under coverage with evidence development (CED). CMS, as a part of this decision, will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a data collection through routine clinical practice or registries. In other words, patient will need to be in a study that collects clinical information into a clinical database. They will not need to be enrolled in a clinical trial.

CMS STATEMENT

As part of the coverage with evidence development (CED), CMS requires that all Medicare patients must be enrolled in a CMS approved clinical registry. The CNU at the BIDMC is the only center in the nation that has a CMS approved clinical registry. We are currently enrolling patients seen in our DiAD clinic into our CMS approved registry and treating Alzheimer’s patients with anti-amyloid therapies, including lecanemab.

LIST OF CMS APPROVED REGISTRIES

These medications are only available to patient with CSF or amyloid-PET confirmation of amyloid. The medications require intravenous infusions (done through the BIDMC infusion clinic) every 2 weeks for up to 18 months and there is a small risk for brain swelling and brain bleeding while on the medication. Medicare will cover 80% of the $26,500 annual cost of this medication.

Patients: If you are interested in learning more about anti-amyloid monoclonal antibody therapy, please signup for our DIAD clinic though this link: ANTI-AMLOID ENROLLMENT

Please leave your name, date of birth, phone, email address. You will be contacted to be scheduled for an evaluation in our DIAD clinic.

Healthcare providers: If you have patients who are interested in learning more about lecanemab, you can enroll them for our DIAD clinic through this link: ANTI-AMYLOID ENROLLMENT.

Please provide your name and the patient’s name, date of birth, and email address. If the patient has completed a recent Montreal Cognitive Assessment (MoCA), Mini Mental Status Exam (MMSE), MiniCog, or AD8 Dementia Screening Interview please include those scores as well. Providing a disease severity stage through the very quick Functional Assessment Staging (FAST) would be helpful.

FAST STAGE:

1. No difficulties, either subjectively or objectively.
2. Complains of forgetting location of objects. Subjective word finding difficulties.
3. Decreased job function evident to co-workers;
   difficulty in traveling to new locations. Decreased organizational capacity.*
4. Decreased ability to perform complex tasks (e.g., planning dinner for guests), handling personal finances (forgetting to pay bills), difficulty marketing, etc.
5. Requires assistance in choosing proper clothing to wear for day, season, occasion.

LECANEMAB

CLICK HERE FOR MORE INFORMATION ABOUT LECANEMAB

The FDA has approved lecanemab for the treatment of Alzheimer’s disease.

Lecanumab is a monoclonal antibody developed by Biogen through partnership with Eisai pharmacuticals that removes a protein called beta-amyloid from the brain. It is infused through a vein for about 1+ hours every two weeks over a total of 18 months. That amounts to 26 infusions in one year and 40 infusion over the 18 months. The infusions have to occur at a BI-Lahey infusion center. In addition, patients will need at least 4 MRI brain scans at BIDMC, and 6 clinic visits in the first year of infusion.

FDA ANNOUNCEMENT

DONANEMAB

CLICK HERE FOR MORE INFORMATION ABOUT DONANEMAB

On May 3, 2023, Eli Lilly and Company announced positive results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. The Phase 3 trial met primary endpoint and all secondary endpoints measuring cognitive and functional decline. Nearly half (47%) of the participants on donanemab (compared to 29% on placebo) had no clinical progression at 1 year (defined as no decline in CDR-SB). Donanemab treatment slowed clinical decline by 35% compared to placebo, and resulted in 40% less decline on the ability to perform activities of daily living. Full results of the TRAILBLAZER-ALZ 2 Phase 3 study will be presented at the Alzheimer’s Association International Conference in July and submitted for publication in a peer-reviewed clinical journal.

Donanemab will require monthly IV infusions for up to 12-18 months. 24% of patients had the side effect of brain swelling and bleeding.

In July 2023, Eli Lilly published the results of their Phase 3 study, TRAILBLAZER-ALZ2 and announced that they have submitted paperwork requesting FDA approval of their medication by the end of the year.

ADUCANEMAB   

In June 2021, the FDA approved aducanumab to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.

The CNU and the BI-Lahey Pharmacy and Therapeutics Committee reviewed the aducanumab data and determined that there is insufficient evidence of benefit to warrant offering this medication to our patients. The Centers for Medicare and Medicaid Services have recommended Biogen run an additional clinical trial to verify the clinical benefit of aducanumab. The CNU will be one of the centers involved in this clinical trial.

If you are interested in participating in this or other clinical trials at the BIDMC, please contact: Memory Research Coordinator 617-667-0249 / alz@bidmc.harvard.edu.