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URMC / Alzheimers Care / Current Research Opportunities
 

Current Research Opportunities

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Leqembi (lecanemab) was granted full FDA approval for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia on July 6, 2023. While this is an exciting step forward in the treatment of Alzheimer’s disease, this medication may not be appropriate for everyone with these diagnoses. If you are interested in finding out if Leqembi (lecanemab) is appropriate for you or your family member, we encourage you to speak with your current Memory Care provider. 

If you are interested in finding out more about clinical trial opportunities with the AD-CARE program, contact us at 585-602-5200.

 

Active studies; open for enrollment:

 

Alzheimer Prevention Trials (APT) Webstudy

If you are 50 years of age or older, you can monitor your own cognitive health by participating in the Alzheimer Prevention Trials (APT) Webstudy.  The APT Webstudy is designed to identify people who may have an increased risk for developing Alzheimer’s disease, using the latest technology to monitor their cognitive performance through regular online memory testing.  Volunteers of the APT Webstudy participate at their convenience, anywhere they have access to the internet.  APT Webstudy participants benefit by:

  • Having their cognitive health assessed over time;
  • Being on the ‘fast track’ for relevant clinical trials to prevent Alzheimer’s;
  • Making an invaluable contribution to advancing Alzheimer’s research, perhaps helping those in the research field find the first Alzheimer’s survivor; and
  • Helping ensure that future generations do not experience Alzheimer’s and its difficult challenges.

To participate in the APT Webstudy or to learn more, please visit www.aptwebstudy.org

 

Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD)

Those identified to have a potential increased risk for memory loss caused by Alzheimer’s disease, will be referred from the APT Webstudy to the Trial Ready Cohort for the Prevention of Alzheimer’s Dementia (TRC-PAD) In-person study.  The purpose of TRC-PAD is to find as many people as possible (also called a “cohort”) who are interested in participating in clinical trials aimed at discovering treatments that will reduce the risk of developing Alzheimer’s dementia. TRC-PAD will help researchers enroll participants into these trials quickly to allow new treatments to be discovered as soon as possible.  Participants do not have to participate in the TRC-PAD study in order to participate in the online APT Webstudy.

 

AHEAD A3-45

The AHEAD A3-45 study is funded by the National Institute on Aging (NIA) in partnership with the Alzheimer’s Clinical Trial Consortium (ACTC), Eisai Co., and collaboration with Biogen Inc. The AHEAD study will test if the investigational treatment, BAN2401, could lower brain amyloid levels and/or prevent cognitive decline in people with amyloid buildup in the brain, in individuals who do not have a diagnosis of a memory disease. For more information, please visit the website: https://www.aheadstudy.org/ 

 

ENVISION

Sponsored by Biogen, Envision is a Phase 3b/4, double-blind, placebo-controlled study with a primary objective of verifying the clinical benefit of monthly doses of aducanumab in people with early Alzheimer's disease.

clinicaltrials.gov/ct2/show/NCT05310071 

 

LIFT-AD

Sponsored by Athira Pharma with funding from the Alzheimer’s Association, this study evaluates the safety and efficacy of an investigation drug (ATH-1017) for the treatment of individuals with mild to moderate Alzheimer's disease. To learn more on about the investigational drug, click here. For more information about the study, please visit: https://classic.clinicaltrials.gov/ct2/show/NCT04488419

 

RETHINK-ALZ

Sponsored by Cassava Sciences, the goal of the study is to investigate the safety and efficacy of simufilam (PT-125) in enhancing cognition and slowing cognitive and functional decline in people with mild to moderate Alzheimer's disease. 

clinicaltrials.gov/ct2/show/NCT04994483.

 

S-CITAD                                                                                                        

Escitalopram for Agitation in Alzheimer’s Disease (S-CitAD)

Agitation is common in people who have Alzheimer’s disease (AD) and can be can be a challenging behavior for the family and friends of these individuals. Agitation affects 42-60 percent of people with Alzheimer’s Disease, and involves emotional distress, excess psychomotor activity, aggression, or disinhibition. Treatment options for agitation in AD are limited. Current approaches are inadequate and better approaches are needed. S-CitAD is a placebo-controlled, masked, randomized clinical trial, sponsored by the National Institute on Aging (NIA). The study is designed to examine the efficacy and safety of escitalopram in combination with a psychosocial intervention (PSI) as treatment for agitation in AD patients. Individuals in the S-CitAD trial will be enrolled for 24-weeks, with treatment for 12 weeks, and additional 12 weeks of safety and efficacy follow-up, for up to 5 clinic visits.

Symptoms of agitation may include, but are not limited to:

Excessive Motor Activity

  • Pacing and aimless wanderingSample Processing
  • Restlessness
  • Repetitive mannerisms (tapping, fidgeting, picking at things)

Verbal Aggression

  • Cursing, shouting or yelling

Physical Aggression

  • Hitting, kicking, pushing or grabbing
  • Throwing things
  • Resisting
  • Slamming doors

More information about the study could be found by visiting www.citadtrial.org

 

SIGNAL- AD

Sponsored by Vaccinex Inc., SIGNAL-AD is a is a Phase 1b/2a trial that investigates the safety, tolerability, effects on cognition and brain metabolism of the study drug pepinemab in early AD dementia (early AD) subjects.

clinicaltrials.gov/ct2/show/NCT04381468

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Studies Coming Soon

 

ADNI4

 

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Active studies; not open for enrollment:

A4

(Anti-Amyloid Treatment in Asymptomatic Alzheimer's study)
 

Conducted by the Alzheimer’s Therapeutic Research Institute (ATRI) in conjunction with Eli Lilly and Company, through a grant from the National Institute on Aging (NIA), this research study focuses on whether a new investigational medication (solanezumab) can slow the progression of memory problems associated with Alzheimer’s disease.

https://clinicaltrials.gov/ct2/show/NCT02008357

 

ALZ-801

Sponsored by Alzheon Inc, this Phase 3 study will investigate the efficacy and tolerability of an investigation drug (ALZ-801) in participants with early AD and who are APOE4/4 carriers.

https://alzheon.com/

 

Clarity AD

Sponsored by Eisai Inc., in collaboration with Biogen Inc., this study assesses safety, tolerability, and efficacy of an experimental medication (BAN2401) in people with early Alzheimer’s disease.

https://clinicaltrials.gov/ct2/show/NCT03887455

 

EMBARK

Sponsored by Biogen Pharmaceuticals, this research study evaluates the long-term safety and tolerability of aducanumab.

https://clinicaltrials.gov/ct2/show/NCT04241068

 

GRADUATE II

Sponsored by Hoffman-La Roche Pharmaceuticals, this study evaluates the efficacy and safety of an investigational medication (gantenerumab) in those with early/mild Alzheimer's disease.

https://clinicaltrials.gov/ct2/show/NCT03443973?term=roche&cond=Alzheimer+Disease&cntry=US&state=US%3ANY&city=Rochester&draw=1&rank=1

 

Lauriet

Sponsored by Genentech, a member of the Roche Group, this research study evaluates the efficacy and safety of an investigational medication (MTAU9937A) in those with moderate Alzheimer’s disease. 

https://clinicaltrials.gov/ct2/show/NCT03828747

 

LEARN

Conducted by the Alzheimer’s Therapeutic Research Institute (ATRI) through a grant from the Alzheimer’s Association, and the National Institute on Aging (NIA), this observational study is a companion study to the A4 Trial to evaluate the rate of cognitive change in older adults that do not have elevated levels of brain amyloid.

https://clinicaltrials.gov/ct2/show/NCT02488720

 

TRAILBLAZER-ALZ 2

Sponsored by the Eli Lilly and Company, this study will evaluate the safety and efficacy of the investigational study drug (donanemab) in participants with early Alzheimer’s disease. 

https://trailblazer2study.com/ 

 

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For more information on additional study opportunities, please visit: https://www.alz.org/research/clinical_trials/find_clinical_trials_trialmatch.asp