Top 10 Alzheimer’s Disease Stories of 2021

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Alzheimer’s News Today brought you coverage of the latest scientific advances, developments in treatment, and clinical trials related to Alzheimer’s disease throughout 2021. We look forward to continuing to report important news for the Alzheimer’s community this year.

Here are the top 10 most-read Alzheimer’s stories of 2021.

No. 10 – “1st Phase 3 Simufilam Trial Enrolling Patients; 2nd Expected by Year’s End

Simufilam is a small molecule designed to bind to an abnormal form of the protein Filamin A that’s found in the brains of people with Alzheimer’s. The therapy’s developer, Cassava Sciences, launched two Phase 3 clinical trials testing the experimental therapy: one, RETHINK–ALZ (NCT04994483), is testing 100 mg of simufilam against a placebo for about a year. The other, REFOCUS–ALZ (NCT05026177), is testing two doses of the investigational treatment (50 or 100 mg) against a placebo for about 1.5 years. Both trials are recruiting people with mild to moderate Alzheimer’s, ages 50 to 87, at sites in the U.S. and Canada.

No. 9 – “GV1001 Treatment Shows Promise for Moderate to Severe Alzheimer’s

GV1001, GemVax & KAEL’s experimental vaccine originally developed to treat cancer, has been shown to have neuroprotective effects. A Phase 2 clinical trial (NCT03184467) enrolled 96 adults with moderate to severe Alzheimer’s who were being treated with Aricept (donepezil) for dementia; participants were given under-the-skin injections of GV1001 (0.56 mg or 1.12 mg), or a placebo, for about six months. Results suggested that treatment with the higher dose of GV1001 slowed the decline in cognitive scores.

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No. 8 – “FDA Extends Its Aducanumab Review With Decision Expected in June

In February 2021, the U.S. Food and Drug Administration (FDA) announced that it was extending its review of Biogen’s amyloid-targeting therapy Aduhelm (aducanumab).

Biogen had terminated development of Aduhelm in 2019 after an interim analysis of two Phase 3 trials indicated that the therapy would not benefit patients, but then reversed course when full data showed that the treatment significantly slowed the decline in cognition in one trial, but not the other.

Later in June, the FDA granted Aduhelm accelerated approval, a decision that garnered substantial controversy.

No. 7 – “Trial Testing ALZ-101 Alzheimer’s Vaccine Recruits First Patient

ALZ-101 is an experimental vaccine for Alzheimer’s being developed by Alzinova AB. The therapy aims to get the body’s immune system to make antibodies that bind to amyloid beta, preventing this protein from clumping up into toxic fibrils that are characteristic of Alzheimer’s. A Phase 1b clinical trial in Finland is seeking to recruit 26 people with Alzheimer’s, who will be given four doses of either the ALZ-101 vaccine or a placebo over about five months. The first participant was dosed in November; results from the study are expected in the first half of 2023.

No. 6 – “Insufficient Evidence of Aducanumab Efficacy, ICER Draft Report Finds
The Institute for Clinical and Economic Review (ICER), an independent non-profit that assesses the effectiveness and value of medical services, issued a draft report in May that found insufficient evidence Aduhelm improves cognition for Alzheimer’s patients. Analyses of cost-effectiveness suggested that, in the best-case scenario, the therapy might be cost-effective at a cost as high as $23,100 per year. Aduhelm’s list price is about $56,000 per year, which has drawn criticism.

No. 5 – “Non-invasive Neurostimulation Device Wins FDA’s Breakthrough Status

Cognito Therapeutics’ neurostimulation device is a next-generation digital therapeutic that’s designed to stimulate the brain non-invasively, using lights and sounds, to help normalize brain activity and reduce brain damage. It received the FDA’s breakthrough device designation, which is meant to speed up the review of treatments with the potential to improve care for serious diseases. Cognito currently is running two clinical trials — Overture (NCT03556280) and Etude (NCT03661034) — testing the investigational device in people with Alzheimer’s.

No. 4 – “Pivotal Phase 3 Trials of Oral Simufilam Planned for Year’s End

Cassava announced in March that it was planning to launch two Phase 3 clinical trials to test simufilam in Alzheimer’s: RETHINK–ALZ (NCT04994483) and REFOCUS-ALZ (NCT05026177). One trial will evaluate the disease-modifying effects of simufilam in Alzheimer’s while the other will evaluate changes in symptoms — specifically, whether simufilam can improve cognition and participation in daily life activities relative to a placebo. FDA officials agreed that findings from these trials, in combination with previous trial data, would be sufficient to show evidence of clinical efficacy for simufilam as an Alzheimer’s treatment. Both trials are currently recruiting.

No. 3 – “Vaccine Sparking Immune Reaction Against Toxic Tau Proteins in Trial

The experimental Alzheimer’s vaccine ACI-35.030 is designed to promote an immune response against an abnormal form of the protein tau, called phosphorylated tau or pTau, which forms toxic clumps in the brains of those with Alzheimer’s. Data from the first 24 participants in an ongoing Phase 1b/2a trial (NCT04445831) indicated that the experimental vaccine induced a robust immune response against pTau, and was generally safe and well-tolerated. ACI-35.030 is being developed by AC Immune in collaboration with Janssen Pharmaceuticals.

No. 2 – “FDA OKs Phase 1 Trial of Nasal Spray Immunotherapy Protollin

Protollin is an experimental nasal spray designed to activate certain parts of the immune system in the brain, prompting these immune cells to help clear abnormal protein aggregates that contribute to Alzheimer’s. The FDA in August gave I-Mab, the therapy’s developer, permission to launch a Phase 1 clinical trial to test the medication in Alzheimer’s patients.

No. 1 – “Oral Simufilam Found to Improve Cognition, Behavior After 6 Months’ Use

Cassava is running an open-label Phase 2 clinical trial (NCT04388254) testing simufilam in people with Alzheimer’s. An interim analysis of the first 50 participants was announced in February, and suggested that the treatment improved cognition: specifically, after six months on simufilam, average scores on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale improved by 10%, while scores on the Neuropsychiatric Inventory improved by 29%. The analysis found no new safety concerns; all reported adverse events (side effects) were mild and resolved with time.

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At Alzheimer’s News Today, we hope that these stories and all of our reporting has been a helpful resource in the past year, and we wish all of our readers a happy 2022.