Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA

Idiopathic Anosmia Clinical Trial

— AROMA  

Official title:

Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05740683
• Other study ID #: H-22053428
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 2032

Study information

• Verified date: February 2023
• Source: Danish Dementia Research Centre
• Contact: Oskar McWilliam
• Phone: +4535458759
• Email: oskar.mcwilliam[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction

Description:

Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.

DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. DLB is like Parkinson's disease (PD), characterized by the accumulation of alpha-synuclein, which misfolds and aggregates within neurons in so-called Lewy Bodies; this assumably drives the neurodegeneration. A novel technique for the measurement of misfolded alpha-synuclein is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process as well as aid in identifying patients with prodromal DLB. This would enable earlier symptomatic relief and care and potentially promote the search for disease-modifying therapies, which is currently absent.

Objectives. The overarching objective of this project is to identify early clinical warning signs and biomarkers in prodromal DLB.

Method. Study 1: Exploratory cross-sectional case-control study of patients with olfactory dysfunction versus individuals without olfactory dysfunction assessing pathological alpha-synuclein by RT-QuIC and prodromal symptoms of DLB and Parkinson's Disease.

Study 2: Longitudinal follow-up in Danish registries on diagnosing PD and dementia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion criteria with patients iOD:

• Age 55 -75 years of age

• Slowly progressing and non-fluctuating iOD

• Able to give informed consent and to cooperate as evaluated by the PI

Exclusion criteria with patients iOD:

• Diagnosed with a neurodegenerative disease or major neurological/psychiatric condition.

• Anosmia/hyposmia caused by sino-nasal disease (including chronic rhinitis and allergy), after trauma, infection, congenial, olfactory dysfunction due to surgery, or toxins/drugs affecting the olfactory function.

• Olfactory dysfunction with response to systemic or local corticosteroids if tried

• Severe nasal cavity abnormalities or infections.

• Overt signs of dementia or PD

• Current alcohol or drug abuse

• Terminal illness

• Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.

Inclusion criteria controls:

• Age 55 -75 years of age

• Able to give informed consent

• Able to cooperate as evaluated by the PI

Exclusion criteria controls:

• Olfactory dysfunction on clinical test

• Overt signs of dementia or PD

• Severe nasal cavity abnormalities or infections.

• Current alcohol or drug abuse

• Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.

Related Conditions & MeSH terms

• Anosmia
• Idiopathic Anosmia
• Neurologic Manifestations

Intervention

Diagnostic Test:
• RT-QuiC
RT-QuIC measures the ability of aSyn to misfold other aSyn proteins and is an amplification technique.

Locations

Country	Name	City	State
Denmark	Danish Dementia Research Centre	Copenhagen
Denmark	Oskar McWilliam	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Danish Dementia Research Centre	Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-time quaking-induced conversion (RT-QuIC) positive for alpha-synuclein (aSyn)		24 months
Primary	Diagnosis of Parkinson's disease (PD) or dementia	A diagnosis of PD or dementia in national databases.	8 years
Secondary	Smell test	Sniffin Sticks identification test (SIT16)	24 months
Secondary	Smell test	Sniffin Sticks 48	24 months
Secondary	Motor function	Unified Parkinson's Rating Scale (UPDRS-III)	24 months
Secondary	Dysautonomia	Unified Parkinson's Rating Scale (UPDRS-I)	24 months