Molecular Imaging of Synaptic Loss in Multiple System Atrophy (MSA)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

In this study the investigators would like to investigate the degree of damage of the synapses, an important part of the neurons vital for the communications between neurons, in Multiple System Atrophy (MSA), and pathology related to abnormal accumulation of a protein named tau, in Progressive Supranuclear Palsy (PSP).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ MSA group:

⁃ Male or female, aged 45-80 at the time of informed consent. Meet criteria for diagnosis of probable or possible MSA (Gilman et al., 2008) (Appendix 1).

⁃ A female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day), is not lactating and is willing to use one of the contraception methods listed below:

• Combined (estrogen and progesterone containing) hormonal contraception associated with initiation of ovulation( oral, intravaginal, or transdermal);

• Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);

• Intrauterine device;

• Intrauterine hormone releasing system;

• Bilateral tubal occlusion;

• Vasectomized partner;

• Sexual abstinence.

⁃ Male subject with a female partner of child-bearing potential must use one of the following contraceptive methods for 90 days after each dose of radiotracer:

• Condom plus partner use of a highly effective contraceptive (see point above) OR

• Abstinence Subjects must understand the nature of the study and be able to provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. They must be able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.

⁃ Must have anticipated survival of ≥3 years (in the opinion of the Investigator).

⁃ Medical treatment of MSA and co-morbid medical conditions must be stable for at least 30 days prior to screening and between screening and baseline PET scan. Intermittently administered treatment may be considered stable if the dose and dosing frequency have been unchanged for the greater of 30 days or three dosing inbiomartervals (e.g. a treatment given once a month must be at a stable dose and dosing frequency for 3 months).

⁃ For inclusion in optional CSF sampling, written informed consent must be provided, either by separate signed and dated written informed consent or by specific written acknowledgement on the main study informed consent form, according to local procedure. Failure to participate in optional CSF sampling will have no influence on the subject's ability to participate in the main study.

⁃ In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have high probability of completing the study.

⁃ PSP Group:

⁃ Male or female, aged 45-80 at the time of informed consent. Meet criteria for diagnosis of suggestive, probable or possible PSP - with preference for PSP-RS, PSP-OM, PSP-PI, PSP with gait freezing, and PSP-SL and PSP-P subtypes (Höglinger et al., 2017 (Appendix 2).

⁃ A female subject is eligible to participate if she is a) of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea or b) of childbearing potential but not pregnant (as determined by urinary pregnancy test on screening and on each study day), is not lactating and is willing to use one of the contraception methods listed below:

• Combined (estrogen and progesterone containing) hormonal contraception associated with initiation of ovulation( oral, intravaginal, or transdermal);

• Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);

• Intrauterine device;

• Intrauterine hormone releasing system;

• Bilateral tubal occlusion;

• Vasectomized partner; Sexual abstinence.

⁃ Male subject with a female partner of child-bearing potential must use one of the following contraceptive methods for 90 days after each dose of radiotracer:

⁃ • Condom plus partner use of a highly effective contraceptive (see point above) OR Abstinence Subjects must understand the nature of the study and be able to provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures. They must be able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.

Locations
Other Locations
United Kingdom
University of Exeter
RECRUITING
Exeter
Contact Information
Primary
Edoardo R. de Natale, MD MSc Ph.D
e.de-natale@exeter.ac.uk
07503741242
Backup
Heather Wilson, MSc Ph.D
h.wilson4@exeter.ac.uk
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 36
Treatments
Patients with MSA
Patients with a diagnosis of MSA and either a clinical form MSA-C or MSA-P
Patients with Progressive Supranuclear Palsy
Patients with a diagnosis of PSP, either the clinical forms PSP-RS or PSP-P
Sponsors
Leads: University of Exeter

This content was sourced from clinicaltrials.gov