Method for the diagnosis of amyloid-associated diseases

A method for the diagnosis and/or prognosis of an amyloid-associated disease in a subject, the amyloid-associated disease being associated with individual amyloid aggregates,

• wherein the method comprises the steps of:
• providing a sample of bodily fluid from the subject,
• adding a detection agent to the sample, the detection agent binding to and/or associating with and/or reacting with individual amyloid aggregates,
• determining the presence and/or amount and/or concentration and/or size of individual amyloid aggregates in the sample;
• wherein determining the presence and/or amount and/or concentration and/or size of individual amyloid aggregates in the sample comprises an analysis based on time-resolved detection comprising fluorescence correlation spectroscopy (FCS) and fluorescence intensity fluctuation analysis (FIFA), and wherein the method does not comprise amplification of individual amyloid aggregates.

A method for the treatment of an amyloid-associated disease in a subject, the amyloid-associated disease being associated with individual amyloid aggregates,

• wherein the method comprises the steps of:
• providing a sample of bodily fluid from the subject,
• adding a detection agent to the sample, the detection agent binding to and/or associates with and/or reacts with individual amyloid aggregates,
• determining the presence and/or amount and/or concentration and/or size of individual amyloid aggregates in the sample,
• identifying the subject as having the amyloid-associated disease on the basis of the determination;
• wherein determining the presence, amount, concentration and/or size of individual amyloid aggregates in the sample comprises an analysis based on time-resolved detection comprising fluorescence correlation spectroscopy (FCS) and fluorescence intensity fluctuation analysis (FIFA), and wherein the method does not comprise amplification of individual amyloid aggregates.

A method for identifying an agent for the treatment of an amyloid-associated disease, wherein the method comprises the steps of:

• providing a first sample of bodily fluid from a test subject;
• determining the presence, amount, concentration and/or size of individual amyloid aggregates in the first sample;
• administering an agent to the subject;
• providing a second sample of bodily fluid from the test subject;
• determining the presence, amount, concentration and/or size of individual amyloid aggregates in the second sample;
• comparing the determination of the presence, amount, concentration and/or size of individual amyloid aggregates in the first sample with the determination of presence, amount, concentration and/or size of individual amyloid aggregates in the second sample;
• identifying the agent as being for the treatment of the amyloid-associated disease based on the comparison;
• wherein the amyloid-associated disease is associated with individual amyloid aggregates, the method further comprises the addition of a detection agent to the sample, the detection agent binding to and/or associating with and/or reacting with individual amyloid aggregates, the determination of the presence and/or amount and/or concentration and/or size of individual amyloid aggregates in the sample comprises an analysis based on time-resolved detection comprising fluorescence correlation spectroscopy (FCS) and fluorescence intensity fluctuation analysis (FIFA), and wherein the method does not comprise amplification of individual amyloid aggregates.

A method for identifying an agent for the treatment of an amyloid-associated disease, wherein the method comprises the steps of:

• providing a first sample from a test fluid;
• determining the presence, amount, concentration and/or size of individual amyloid aggregates in the first sample;
• administering an agent to the test fluid;
• providing a second sample from the test fluid;
• determining the presence, amount, concentration and/or size of individual amyloid aggregates in the second sample;
• comparing the determination of the presence, amount, concentration and/or size of individual amyloid aggregates in the first sample with the determination of presence, amount, concentration and/or size of individual amyloid aggregates in the second sample;
• identifying the agent as being for the treatment of the amyloid-associated disease based on the comparison;
• wherein the amyloid-associated disease is associated with individual amyloid aggregates, the method further comprises the addition of a detection agent to the sample, the detection agent binding to and/or associating with and/or reacting with individual amyloid aggregates, the determination of the presence and/or amount and/or concentration and/or size of individual amyloid aggregates in the sample comprises an analysis based on fluorescence correlation spectroscopy (FCS) and fluorescence intensity fluctuation analysis (FIFA), and wherein the method does not comprise amplification of individual amyloid aggregate.