Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. All enrolled patients must be over the age of 18, speak English as their primary
language, and have an informant who can provide an independent evaluation of
functioning.
2. Each new patient must present with a chief complaint of progressive impairment of
speech and must have evidence of AOS documented by a speech-language pathologist
during routine clinical evaluation.
3. At study entry, all patients must have speech sufficiently intelligible for a
confident diagnosis of AOS, dysarthria, and/or aphasia, and for acoustic analysis.
Exclusion Criteria:
1. Any patient whose speech is not intelligible enough for confident speech-language
diagnosis will be excluded from the study.
2. All patients with concurrent illnesses that could account for speech deficits (e.g.,
traumatic brain injury, strokes, developmental syndromes), and patients meeting
criteria for another neurodegenerative disease (e.g., Alzheimer's type dementia57),
will be excluded.
3. Patients with aphasia or dysarthria who do not have PAOS, or whose aphasia or
dysarthria at study entry is more severe than PAOS, will be excluded.
4. All women who are pregnant, or post-partum and breast-feeding, will be excluded as
they are unable to undergo the required imaging. All women who can become pregnant
must have a pregnancy test no more than 48 hours before the DaTscan.
5. Patients will also be excluded if MRI is contraindicated (e.g., metal in head, cardiac
pace maker), if there is severe claustrophobia, if there are conditions that may
confound brain imaging studies (e.g. structural abnormalities, including subdural
hematoma or intracranial neoplasm), or if they are medically unstable or are on
medications that might affect brain structure or metabolism (e.g. chemotherapy).
6. Patients will be excluded if they do not have an informant, or do not consent to the
research.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 7/18/23. Questions regarding updates should be directed to the study team contact.