Quantification of Hsp90 in Neurodegenerative Diseases Using PET Radioligand [11C]HSP990 in Alzheimer's, ALS, and Parkinson's Disease

The primary objective of this study is to evaluate the **in vivo** quantification of **Hsp90** in the human brain using the novel PET radioligand [11C]HSP990. This is particularly relevant in the context of healthy aging and neurodegenerative conditions such as **Alzheimer's Disease**, **Amyotrophic Lateral Sclerosis**, and **Parkinson's Disease**. Understanding the distribution and concentration of Hsp90 in these conditions could provide insights into the pathophysiology of neurodegeneration and potentially guide therapeutic strategies.

The clinical trial involves participants diagnosed with **Alzheimer's Disease**, **Amyotrophic Lateral Sclerosis**, or **Parkinson's Disease**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed by the sponsor. Key inclusion or exclusion criteria are also not specified in the available data.

The clinical trial is designed to investigate the in vivo quantification of **Hsp90** in the human brain using a novel PET radioligand, [11C]HSP990, focusing on healthy aging and neurodegenerative conditions such as **Alzheimer's Disease**, **Amyotrophic Lateral Sclerosis**, and **Parkinson's Disease**. This study is structured as a Phase 1 trial, which typically involves a small group of participants to evaluate safety, dosage, and initial efficacy. The trial is expected to commence recruitment on June 17, 2024, and is projected to conclude by December 1, 2027.

The trial will follow a randomized, double-blind, controlled design to ensure unbiased results and maintain the integrity of the data collected. Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Subsequent follow-up visits will be scheduled to monitor the participants' response to the intervention and to collect necessary data at various intervals throughout the study duration. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to evaluate the outcomes of the intervention.

Participant involvement is expected to last for the entire duration of the trial, from the initial screening to the end-of-study visit. However, certain conditions may necessitate early termination from the study, such as adverse reactions, non-compliance with study protocols, or withdrawal of consent by the participant. The trial's methodology and design are meticulously crafted to ensure the collection of reliable and valid data, contributing to the understanding of Hsp90's role in neurodegenerative diseases.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is June 17, 2024, with an anticipated end date of December 1, 2027. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of therapeutic effects alongside safety evaluations. The trial will likely employ standardized methods for measuring and collecting data, which may include laboratory tests and validated scales, to ensure the reliability and validity of the results. The analysis of efficacy will be conducted in accordance with established clinical trial protocols, ensuring that the findings contribute to the understanding of the investigational product's potential benefits.