25 Participants Needed

AMDX-2011P for Alzheimer's Disease

Recruiting at 2 trial locations
JS
DB
Overseen ByDavid Bingaman, DVM, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Amydis Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with Alzheimer's Disease (AD).

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.

What data supports the idea that AMDX-2011P for Alzheimer's Disease is an effective treatment?

The available research does not provide any specific data on the effectiveness of AMDX-2011P for Alzheimer's Disease. Instead, it discusses other treatments like donepezil and acetyl-L-carnitine. Donepezil has been shown to be effective in both mild to moderate and more severe stages of Alzheimer's Disease, while acetyl-L-carnitine showed potential benefits for younger patients with early-onset Alzheimer's. However, there is no information on AMDX-2011P in the provided research.12345

What safety data is available for AMDX-2011P in Alzheimer's treatment?

The provided research does not mention AMDX-2011P or its variants directly. 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, and AVP-786, each with their own safety profiles, but none of these are identified as AMDX-2011P.46789

Is the drug AMDX-2011P a promising treatment for Alzheimer's Disease?

The information provided does not mention AMDX-2011P, so we cannot determine if it is a promising treatment for Alzheimer's Disease based on the given research articles.34101112

Research Team

DB

David Bingaman, DVM, PhD

Principal Investigator

Amydis Inc.

Eligibility Criteria

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.
See 2 more

Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AMDX-2011P 100 milligramExperimental Treatment1 Intervention
AMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amydis Inc.

Lead Sponsor

Trials
4
Recruited
140+

Findings from Research

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.
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]
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.
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 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.
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]

References

Efficacy and safety of donepezil over 3 years: an open-label, multicentre study in patients with Alzheimer's disease. [2018]
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. [2022]
A 1-year multicenter placebo-controlled study of acetyl-L-carnitine in patients with Alzheimer's disease. [2019]
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. [2016]
Efficacy and safety of donepezil in patients with more severe Alzheimer's disease: a subgroup analysis from a randomized, placebo-controlled trial. [2018]
AMPA potentiator treatment of cognitive deficits in Alzheimer disease. [2022]
Open-Label, Multicenter, Phase III Extension Study of Idalopirdine as Adjunctive to Donepezil for the Treatment of Mild-Moderate Alzheimer's Disease. [2020]
AVP-786 for the treatment of agitation in dementia of the Alzheimer's type. [2017]
Frequency and Severity of Adverse Drug Reactions to Medications Prescribed for Alzheimer's Disease in a Brazilian City: Cross-Sectional Study. [2021]
Trials to slow progression and prevent disease onset. [2019]
[Imaging of brain acetylcholinesterase activity in dementias and extrapyramidal disorders]. [2008]
12.United Statespubmed.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. [2022]
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