Alzheimer's Clinical Trials

Alzheimer’s Clinical Trials Overview

Hattiesburg Clinic conducts clinical trials that focus on neurological therapeutics, with Alzheimer’s disease and mild cognitive impairment (MCI) being areas of special interest and expertise. Basic research techniques generate ideas about which medical strategies may be likely to help alleviate symptoms of an illness or disease. Clinical research protocols are then developed in order to test these hypotheses.

Clinical trials are designed to determine if a new treatment will be both safe and effective for patients. In addition, trials will often collect data to determine whether an investigational strategy will have a broader influence on related problems such as activities of daily living, caregiver stress or general quality of life.

Clinical trials in memory loss disorders will usually involve both patients and caregivers. While trial participation is completely voluntary, it is important to recognize the time and effort involved in the successful completion of a clinical trial.

Hattiesburg Clinic is gratified to be able to offer our community access to potential new treatments for memory disorders. New treatments can only be discovered through the partnership of patient volunteers, research sites, and scientific sponsors. Everyone plays an important role in this investigational process. Every day, we work with hopeful optimism towards more effective therapies, more accurate diagnoses, and eventually a sustainable cure for these types of diseases.

None of this happens without your help.

Currently Enrolling Trials

Avanir – Aspect (20-AVP-786-036} NCT04408755

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q)) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer’s type.

Eligible participants for this study must have a diagnosis of probable Alzheimer’s disease (AD} and must have clinically significant, moderate/severe agitation secondary to AD. This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment.

New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study NCT04426539

New IDEAS is an observational, open-label, longitudinal cohort study designed to address the requirements of the CED provisions of the NCD on beta-amyloid PET. Building on the initial Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, New IDEAS will evaluate the association between amyloid PET and patient-centered outcomes in an expanded and more ethnoracially and clinically diverse group of Medicare participants presenting with cognitive impairment.

For more information, visit ideas-study.org/For-Patients

Cognito – Hope (CA-0011) NCT05637801

This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer’s disease. Approximately 530 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will bemeasured using the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL} assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).

Learn More

Active Non-Enrolling Trials

Alector – Invoke (AL002-2} NCT04592874

This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer’s Disease.

Biogen – ENVISION (221AD305} NCT05310071

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB} score as compared with placebo in participants with early Alzheimer’s disease.

evoke/evoke+ (NN6535-4730/4725} NCT04777396 and NCT04777409

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer’s disease. Participants will either get semaglutide or placebo (a “dummy” medicine which does not contain any study medicine) -which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months).

For more information, visit evokeadstudy.com

Janssen – Autonomy (63733657ALZ2002) NCT04619420

The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer’s Disease Rating Scale (iADRS), a composite of cognition and function.

JNJ-63733657 is a humanized monoclonal anti-tau antibody which binds to phosphorylated tau (P-tau). The study will evaluate whether JNJ-63733657 can slow clinical (cognitive and functional) decline in participants with Early AD with evidence of elevated brain tau (T+) and assess its safety and tolerability. The study consists of: screening period (13 weeks), double­ blind treatment period (up to 232 weeks), and a follow-up period (13 weeks).

Clarity AD (BAN2401-G000-301) NCT03887455

This study will be conducted to evaluate the efficacy of BAN2401 in participants with early Alzheimer’s disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of BAN2401 in participants with EAD in the Extension Phase and whether the long­ term effects of BAN2401 as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

For more information please visit clarityadstudy.com

For More Information Regarding Clinical Trial Participation

Why Participate?

http://www.nih.gov/health/clinicaltrials/whyparticipate.htm

Common Questions

http://www.nih.gov/health/clinicaltrials/basics.htm

Alzheimer’s Research

https://www.nia.nih.gov/alzheimers/clinical-trials

Participating in Alzheimer’s Research

https://www.nia.nih.gov/health/participating-alzheimers-disease-research

Neurology
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