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

Alzheimer’s Disease and Related Disorders Association, Inc – Alz-Net / NCT06170268

The Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) will collect longitudinal clinical and safety data for enrolled patients being evaluated for or treated with novel FDA-approved Alzheimer’s disease (AD) therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET is a resource for evidence gathering, information sharing and education across clinical and research communities, encouraging innovative research and supporting opportunities to improve clinical care delivery. All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines.

Bristol-Myers Squibb – Mindset (CN012-0052) NCT06976203

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer’s Disease.

This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KarXT + KarX-EC for the treatment of cognitive impairment associated with mild to moderate Alzheimer’s Disease (MINDSET 2).

Bristol-Myers Squibb – Adagio (CN012-0024 / 25) NCT07011745

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer’s Disease.

This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of KarXT + KarX-EC for the treatment of agitation associated with Alzheimer’s Disease (ADAGIO-2).

Lighthouse Pharmaceuticals, Inc. – SPRING (LHP588-201) NCT06847321

This study is to test LHP588 in persons who have mild to moderate Alzheimer’s disease (AD) who have shown progressive mental decline in the last year and who have P. gingivalis (Pg) infection. P. gingivalis infection has been linked to the development of dementia. LHP588 is designed to target the P. gingivalis bacterium, to potentially help to halt or slow down the progression of AD and its symptoms. A saliva test will be done to determine P. gingivalis infection. Tests for AD include standard questionnaires such as MMSE and a blood test for pTau217. Treatment will be blinded, meaning the participant and the doctor will not know if the participant is receiving LHP588 or placebo. The total time for participation in the study may be up to 64 weeks. This includes a screening period (to ensure the participant is suitable for the study and the study is suitable for the participant) of up to 12 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of four weeks after the last dose of the study drug to check the participant’s overall health. Treatment is a once-a-day capsule. Caregiver participation is required. The study requires the participant to visit the study center (with the caregiver) at least 20 times within 64 weeks (this does not include any unplanned visits that may be recommended by the study doctor). In addition, the study doctor or clinic staff will contact the participant via phone at least one time.

This is a randomized, double-blind, placebo-controlled study of LHP588 in subjects with P. Gingivalis-Positive Alzheimer’s Disease.

Active Non-Enrolling Trials

Acumen – Altitude (ACU193-201) / NCT06335173

This is a phase 2 double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of intravenous sabirnetug in early Alzheimer’s Disease. The primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer’s disease.

Cognito – Hope (CA-0011) / NCT05637801 / Cognito – Hope OLE (CA-0015)

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 be measured 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).

Eisai – E2814-G000-202 / NCT06602258

The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 18 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer’s disease (AD). This is a phase 2, placebo-controlled, double-blind, parallel-group, dose-finding study to evaluate safety, tolerability, and biomarker efficacy of E2814 with concurrent Lecanemab treatment in subjects with early Alzheimer’s Disease.

Eli Lilly – Trailrunner Alz-3 (J1G-MC-LAKI) / NCT06653153

This is a study of remternetug versus placebo in early Alzheimer’s Disease participants at risk for cognitive and functional decline.

The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer’s disease occurring in participants receiving study drug compared to placebo. Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label Remternetug in an extension period.

Recently Completed Trials

Janssen – Retain (64042056AZLZ2001) / NCT 06544616

The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer’s disease Cognitive Composite 5 (PACC-5) compared with placebo. This is a multicenter, randomized, placebo-controlled, double-blind, parallel-group study, to assess efficacy, safety and immunogenicity of JNJ-64042056, a phosphorylated tau targeted active immunotherapy, in participants with preclinical 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 three years and four months).

For more information, visit evokeadstudy.com.

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.

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).

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

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