AMDX-2011P for Alzheimer's Disease

Recruiting at 2 trial locations

Overseen By David Bingaman, DVM, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amydis Inc.

Disqualifiers: Glaucoma, Macular degeneration, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment, AMDX-2011P, for individuals with Alzheimer's Disease (AD). Researchers seek to understand how a single dose of this treatment behaves in the body and whether it shows promise in alleviating AD symptoms. The trial requires participants diagnosed with AD who have had a brain scan revealing a specific protein linked to the disease. Participants must also consent to a genetic test and be able to undergo eye imaging tests. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for more details.

Is there any evidence suggesting that AMDX-2011P is likely to be safe for humans?

Research shows that specific safety information for AMDX-2011P in humans is not yet available. However, the current trial is in Phase 2, indicating that the treatment has shown promise in earlier tests. In this phase, researchers test the treatment on a small group of people to assess tolerance and identify any side effects.

Another study is examining AMDX-2011P in individuals with a condition related to Alzheimer’s. This study evaluates the drug's safety and behavior in the body. Although specific safety data is not yet available, testing AMDX-2011P in multiple studies marks progress toward understanding its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's Disease?

Researchers are excited about AMDX-2011P for Alzheimer's disease because it offers a unique approach to diagnosis and treatment. Unlike most current treatments, which primarily focus on managing symptoms, AMDX-2011P is administered as a single intravenous bolus injection, potentially offering a quick and effective diagnostic review. This innovative delivery method could streamline the diagnosis process, making it faster and more accurate, which is crucial for early intervention in Alzheimer’s disease. By targeting the underlying mechanisms with precision, AMDX-2011P could pave the way for more personalized treatment strategies.

What evidence suggests that AMDX-2011P might be an effective treatment for Alzheimer's Disease?

Research shows that AMDX-2011P, administered to participants in this trial, is under study for its potential to detect Alzheimer's disease by targeting amyloid beta. Amyloid beta is a protein that often accumulates in individuals with Alzheimer's. Previous studies have demonstrated that using AMDX-2011P as an ocular tracer could help identify these protein buildups. Detecting amyloid beta early is crucial, as it may lead to earlier Alzheimer's diagnosis. Although researchers are still investigating this method, its focus on a known Alzheimer's factor is promising. ^{1 3 6 7 8}

Who Is on the Research Team?

David Bingaman, DVM, PhD

Principal Investigator

Amydis Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's Disease confirmed by a PET brain scan. Participants must be willing to undergo genetic testing and retinal imaging, and have the ability to fixate during these procedures. Those with heart rhythm issues, significant ECG abnormalities, psychological conditions likely to prevent study completion, glaucoma or certain forms of macular degeneration cannot join.

Inclusion Criteria

I am willing to undergo genetic testing for APOE.

Ability to fixate and undergo retinal imaging of both eyes

I have Alzheimer's with a positive amyloid PET scan.

Exclusion Criteria

My heart's electrical activity is normal as per my last ECG.

Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol

I have been diagnosed with or suspected of having glaucoma by an eye doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single intravenous bolus injection of AMDX-2011P followed by safety assessments, retinal imaging, and PK blood collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including detection of amyloid deposits in the retina

8 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AMDX-2011P

Trial Overview

The study tests AMDX-2011P administered as a single intravenous dose in people with Alzheimer's Disease. It aims to evaluate the safety, how well it's tolerated, its presence in blood over time (pharmacokinetics), and its biological effects on patients.

How Is the Trial Designed?

Group I: AMDX-2011P 100 milligram Experimental Treatment 1 Intervention

AMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review

Who Is Running the Clinical Trial?

Amydis Inc.

Lead Sponsor

Trials

4

Recruited

140+

Published Research Related to This Trial

AVP-786, a new investigational drug combining deuterated dextromethorphan and quinidine, shows promise for treating agitation in Alzheimer-type dementia, with a favorable pharmacokinetic profile that enhances its effectiveness and safety.

Previous studies, including a phase II trial with over 200 patients, indicated that AVP-923 (a related compound) effectively reduced agitation and was well tolerated, supporting the potential of AVP-786 in ongoing phase III trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVP-786 for the treatment of agitation in dementia of the Alzheimer's type. Garay, RP., Grossberg, GT.[2017]

In a 1-year study involving 431 patients with probable Alzheimer's disease, acetyl-L-carnitine hydrochloride (ALCAR) did not show a significant difference in cognitive decline compared to placebo for the overall group, indicating similar efficacy between the two treatments.

However, a subanalysis suggested that early-onset Alzheimer's patients (aged 65 or younger) may experience a slower decline with ALCAR compared to those on placebo, while late-onset patients may progress more rapidly on ALCAR, highlighting the need for further research in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 1-year multicenter placebo-controlled study of acetyl-L-carnitine in patients with Alzheimer's disease. Thal, LJ., Carta, A., Clarke, WR., et al.[2019]

In a study involving 144 subjects with amnestic mild cognitive impairment, AL-108 was found to be generally safe and well tolerated over 12 weeks of treatment.

While the overall efficacy analysis did not show a significant difference in cognitive memory scores between AL-108 and placebo, there were promising signals of potential efficacy in specific memory and attention tasks, suggesting further research is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment. Morimoto, BH., Schmechel, D., Hirman, J., et al.[2016]

The fixed-dose combination (FDC) capsule of 28 mg memantine extended release and 10 mg donepezil is bioequivalent to the separately administered medications, which may enhance treatment adherence for Alzheimer's disease.

The bioavailability of the FDC is not affected by food intake or by sprinkling the capsule contents on applesauce, indicating flexible administration options without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel once-daily fixed-dose combination of memantine extended release and donepezil for the treatment of moderate to severe Alzheimer's disease: two phase I studies in healthy volunteers. Boinpally, R., Chen, L., Zukin, SR., et al.[2022]

In a study of 290 patients with moderate to severe Alzheimer's disease, donepezil significantly improved global, cognitive, functional, and behavioral measures compared to placebo over 24 weeks, particularly in patients with more severe symptoms (sMMSE score 5-12).

The treatment effects of donepezil were consistent across varying levels of disease severity, indicating its efficacy is not limited to a specific stage within moderate to severe Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of donepezil in patients with more severe Alzheimer's disease: a subgroup analysis from a randomized, placebo-controlled trial. Feldman, H., Gauthier, S., Hecker, J., et al.[2018]

In a study of 250 Alzheimer's patients in Brazil, 83.6% reported at least one adverse drug reaction (ADR), with rivastigmine causing the highest number of ADRs at an average of 7.9 per patient.

Most ADRs were mild and related to psychiatric disorders, highlighting the need for improved safety measures in prescribing Alzheimer's medications, especially given the patients' vulnerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Severity of Adverse Drug Reactions to Medications Prescribed for Alzheimer's Disease in a Brazilian City: Cross-Sectional Study. Ferreira, TR., Lopes, LC., Bergamaschi, CC.[2021]

Carbon-11 labeled acetylcholine analogues, [11C]MP4A and [11C]MP4P, effectively measure brain acetylcholinesterase (AChE) activity in vivo, revealing significant reductions in AChE activity associated with various types of dementia, particularly in early-onset Alzheimer's disease.

The study found that AChE activity is notably reduced in the cerebral cortex of patients with Alzheimer's disease, Parkinson's disease with dementia, and dementia with Lewy bodies, indicating that these measurements could help in understanding the progression of neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Imaging of brain acetylcholinesterase activity in dementias and extrapyramidal disorders]. Shinotoh, H.[2008]

Idalopirdine, when used as an adjunctive therapy in patients with mild to moderate Alzheimer's disease, demonstrated good tolerability over an extended period of up to 18 months, with treatment-emergent adverse events reported in 51-59% of patients, but no new safety concerns were identified.

Despite its safety profile, idalopirdine did not show consistent efficacy benefits when added to donepezil or memantine, indicating that while it is safe for long-term use, it may not provide significant therapeutic advantages in treating Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-Label, Multicenter, Phase III Extension Study of Idalopirdine as Adjunctive to Donepezil for the Treatment of Mild-Moderate Alzheimer's Disease. Frölich, L., Atri, A., Ballard, C., et al.[2020]

Current Alzheimer's disease treatments mainly focus on improving symptoms rather than halting disease progression, with only selegiline and vitamin E showing any delay in important clinical endpoints.

Research is ongoing for new treatments aimed at slowing progression or preventing onset, including antioxidants, anti-inflammatory agents, and drugs targeting amyloid deposition, with trials also focusing on preventing Alzheimer's in individuals with mild cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials to slow progression and prevent disease onset. Thal, LJ.[2019]

In a 132-week study involving 579 patients with mild to moderate Alzheimer's disease, donepezil demonstrated long-term efficacy, with cognitive improvements observed after 6 weeks of treatment and slight improvements in dementia ratings over the first 12 weeks.

Donepezil was generally well tolerated, although 85% of patients experienced at least one adverse event, with common side effects including diarrhea, nausea, and infections, indicating that while effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of donepezil over 3 years: an open-label, multicentre study in patients with Alzheimer's disease. Burns, A., Gauthier, S., Perdomo, C.[2018]

In an 11-week study involving 181 patients with mild to moderate Alzheimer's disease, the alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid modulator LY451395 did not show significant improvement in cognitive function compared to placebo, as measured by the ADAS-Cog scale.

While there were some marginal improvements in neuropsychiatric symptoms after 8 weeks of treatment, the overall safety profile was similar between LY451395 and placebo, with most adverse events being mild.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMPA potentiator treatment of cognitive deficits in Alzheimer disease. Chappell, AS., Gonzales, C., Williams, J., et al.[2022]

In a study of 201 sedentary older adults with amnestic mild cognitive impairment (aMCI), slower usual gait speed and longer times on the Timed 'Up & Go' Test were significantly associated with poorer performance on executive function tests, indicating a link between physical performance and cognitive abilities.

These findings suggest that monitoring gait and mobility could be important for assessing cognitive decline in older adults with aMCI, although the study's cross-sectional design means we cannot determine if one directly causes the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between physical performance and executive function in older adults with mild cognitive impairment: gait speed and the timed "up & go" test. McGough, EL., Kelly, VE., Logsdon, RG., et al.[2022]

Citations

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A Study of AMDX-2011P in Participants With Alzheimer's ...

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome ...

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cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/76/NCT05542576/Prot_000.pdf

CLINICAL STUDY PROTOCOL

Title: Prospective Randomized Open, Blinded Endpoint (PROBE). Study of AMDX-2011P as a Retinal Tracer in Subjects with. Neurodegenerative Diseases ...

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nia.nih.gov

nia.nih.gov/research/ongoing-AD-trials

NIA-Funded Active Alzheimer's and Related Dementias ...

NIA is currently supporting over 400 active clinical trials on Alzheimer's disease and dementia in many areas of research. See the comprehensive list.

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synapse-patsnap-com.libproxy1.nus.edu.sg/drug/21060bf0a835488fac99ae9e9af55e73

AMDX2011P - Drug Targets, Indications, Patents - Synapse

A Phase 2, Open Label, Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimer's Disease ... Clinical Results associated with AMDX2011P.

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biospace.com/amydis-launches-phase-2-glaucoma-clinical-program-using-novel-retinal-tracer-to-detect-amyloid-beta

Amydis Launches Phase 2 Glaucoma Clinical Program ...

Converging data indicate that amyloid beta, best known for its association with Alzheimer's disease, is a key factor in glaucoma pathogenesis.

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withpower.com

withpower.com/trial/phase-2-alzheimer-disease-6-2024-bd0af

AMDX-2011P for Alzheimer's Disease

Therefore, no specific safety data for AMDX-2011P is available in the given studies. The studies focus on other treatments like LY451395, AL-108, idalopirdine, ...

7.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/amydis-cerebral-amyloid-angiopathy/

Amydis begins enrolment in cerebral amyloid angiopathy ...

The trial will evaluate the pharmacokinetics, tolerability, activity, and safety of escalating intravenous doses of AMDX-2011P in CAA patients.

8.

amydis.com

amydis.com/2023/02/21/amydis-announces-enrollment-of-cerebral-amyloid-angiopathy-participants-in-phase-1-2a-retinal-tracer-trial/

Amydis Announces Enrollment of Cerebral Amyloid ...

CAA develops in up to 23% of the general population with aging, and it occurs at a higher rate of ~48% in people with Alzheimer's disease due to ...