SchizophreniaPhase 1NCT05105542

M1 Schizophrenia PET Study

A Phase 1 study testing 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor and PET Scan in people with Schizophrenia and Schizoaffective Disorder, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia, Schizoaffective Disorder, Healthy
What is being tested?: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor and PET Scan
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 20 Apr 2021to 31 Oct 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men and women aged 18- 65 years that are physically and mentally healthy with the exception of DSM-5 schizophrenia or schizoaffective disorder diagnosis
Subjects with no metal in the body that may pose a risk during MRI scanning
No significant medical history, including head trauma and bleeding disorders

Who cannot join

Men and women with a history or presence of clinically significant medical conditions
People who suffer from claustrophobia, have MRI incompatible implants, or other contraindications for MRI and PET scans

Trial locations and contacts

1 site in 1 country.

United States1 site

Connecticut Mental Health Center
New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: Muscarinic M1 Receptor Availability and Cognition in Schizophrenia

This exploratory study seeks to examine M1 receptor availability in SZ patients and to relate M1 receptor availability to proximal and distal measures of cognitive performance, namely evoked ɣ oscillations in the EEG and verbal memory. Furthermore, the relationship between hippocampal [11C]EMO availability (BPND), evoked ɣ oscillations, verbal memory, and measures of illness severity will be explored.

Read the detailed description

Converging lines of evidence from postmortem studies provide strong evidence that brain muscarinic M1 receptor deficit is present in a subset of schizophrenia (SZ) patients. M1 receptors are an important target for cognitive deficits in SZ. However, until now, it has not been possible to examine the heterogeneity of SZ with respect to M1 receptor availability in vivo. The development of a novel positron emission tomography (PET) ligand, [11C]EMO, at Yale PET Center provides a unique opportunity to, for the first time, examine in vivo brain muscarinic M1 receptor availability in SZ and, concurrently, elucidate the relationship of M1 receptors to cognitive deficits in SZ.

The investigators will compare M1 receptor availability in SZ patients and age-, gender-matched healthy controls using [11C]EMO and the High Resolution Research Tomograph (HRRT), a PET scanner with high sensitivity and resolution available for human brain imaging. This study will explore the relationship between: hippocampal [11C]EMO binding (as a measure of hippocampal M1 AChR availability), encoding-related γ power during a verbal memory task, verbal memory, gender, and serum acetylcholine level. This exploratory study will provide the necessary pilot data to conduct a larger study to fully investigate the heterogeneity of SZ with respect to M1 receptor availability.

Conditions: Schizophrenia, Schizoaffective Disorder, Healthy
Being tested: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor, PET Scan
Keywords: Schizophrenia, Muscarinic M1 Receptor, M1 AChR, [11C]EMO, PET Scan, MRI Scan
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

11C-EMO - A Novel PET Radiotracer for Muscarinic M1 ReceptorDrug
The radiotracer, [11C]EMO, will be administered at the beginning of each PET scan.
PET ScanDevice
PET scanner with high sensitivity and resolution available for human brain imaging

Study groups in NCT05105542
Study group	Role	What they receive
Schizophrenia or schizoaffective disorder	Experimental	Participants will undergo a single PET scan with [11C]EMO ≤ 20 mCi Receives: Drug: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor; Device: PET Scan
Healthy Controls	Experimental	Participants will undergo a single PET scan with [11C]EMO ≤ 20 mCi Receives: Drug: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor; Device: PET Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

Hippocampal M1 availability
Measured by [11C]EMO availability (BPND)
Measured: 10 days

Secondary outcomes (2)

evoked ɣ oscillations
Measured by EEG
Measured: 10 days
verbal memory
Measured by cognitive assessments
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 202131 Oct 2023

First posted3 Nov 2021
Study start20 Apr 2021
Primary completion31 Oct 2023
Study completion31 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (58)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Two groups will be studied: 1.) patients diagnosed with schizophrenia or schizoaffective disorder, and 2.) age and gender-matched healthy controls. Both groups will undergo neuroimaging, cognitive assessments, etc.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05105542
Sponsor's protocol ID: 2000031171
Other IDs: 1R21MH123870-01A1, 1R01MH113557-01
Status last verified: Nov 2024
First submitted: 22 Oct 2021
Last updated: 12 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Mogg AJ, Eessalu T, Johnson M, Wright R, Sanger HE, Xiao H, Crabtree MG, Smith A, Colvin EM, Schober D, Gehlert D, Jesudason C, Goldsmith PJ, Johnson MP, Felder CC, Barth VN, Broad LM. In Vitro Pharmacological Characterization and In Vivo Validation of LSN3172176 a Novel M1 Selective Muscarinic Receptor Agonist Tracer Molecule for Positron Emission Tomography. J Pharmacol Exp Ther. 2018 Jun;365(3):602-613. doi: 10.1124/jpet.117.246454. Epub 2018 Apr 11.
PubMed 29643252
Oki T, Takagi Y, Inagaki S, Taketo MM, Manabe T, Matsui M, Yamada S. Quantitative analysis of binding parameters of [3H]N-methylscopolamine in central nervous system of muscarinic acetylcholine receptor knockout mice. Brain Res Mol Brain Res. 2005 Jan 5;133(1):6-11. doi: 10.1016/j.molbrainres.2004.09.012.
PubMed 15661360
Smart K, Gallezot JD, Nabulsi N, Labaree D, Zheng MQ, Huang Y, Carson RE, Hillmer AT, Worhunsky PD. Separating dopamine D2 and D3 receptor sources of [11C]-(+)-PHNO binding potential: Independent component analysis of competitive binding. Neuroimage. 2020 Jul 1;214:116762. doi: 10.1016/j.neuroimage.2020.116762. Epub 2020 Mar 19.
PubMed 32201327
Worhunsky PD, Matuskey D, Gallezot JD, Gaiser EC, Nabulsi N, Angarita GA, Calhoun VD, Malison RT, Potenza MN, Carson RE. Regional and source-based patterns of [11C]-(+)-PHNO binding potential reveal concurrent alterations in dopamine D2 and D3 receptor availability in cocaine-use disorder. Neuroimage. 2017 Mar 1;148:343-351. doi: 10.1016/j.neuroimage.2017.01.045. Epub 2017 Jan 19.
PubMed 28110088
Carruthers SP, Van Rheenen TE, Gurvich C, Sumner PJ, Rossell SL. Characterising the structure of cognitive heterogeneity in schizophrenia spectrum disorders. A systematic review and narrative synthesis. Neurosci Biobehav Rev. 2019 Dec;107:252-278. doi: 10.1016/j.neubiorev.2019.09.006. Epub 2019 Sep 7.
PubMed 31505202
Niendam TA, Ray KL, Iosif AM, Lesh TA, Ashby SR, Patel PK, Smucny J, Ferrer E, Solomon M, Ragland JD, Carter CS. Association of Age at Onset and Longitudinal Course of Prefrontal Function in Youth With Schizophrenia. JAMA Psychiatry. 2018 Dec 1;75(12):1252-1260. doi: 10.1001/jamapsychiatry.2018.2538.
PubMed 30285056
Van Rheenen TE, Cropley V, Zalesky A, Bousman C, Wells R, Bruggemann J, Sundram S, Weinberg D, Lenroot RK, Pereira A, Shannon Weickert C, Weickert TW, Pantelis C. Widespread Volumetric Reductions in Schizophrenia and Schizoaffective Patients Displaying Compromised Cognitive Abilities. Schizophr Bull. 2018 Apr 6;44(3):560-574. doi: 10.1093/schbul/sbx109.
PubMed 28981831
Wells R, Swaminathan V, Sundram S, Weinberg D, Bruggemann J, Jacomb I, Cropley V, Lenroot R, Pereira AM, Zalesky A, Bousman C, Pantelis C, Weickert CS, Weickert TW. The impact of premorbid and current intellect in schizophrenia: cognitive, symptom, and functional outcomes. NPJ Schizophr. 2015 Nov 4;1:15043. doi: 10.1038/npjschz.2015.43. eCollection 2015.
PubMed 27336046
Scarr E, Craig JM, Cairns MJ, Seo MS, Galati JC, Beveridge NJ, Gibbons A, Juzva S, Weinrich B, Parkinson-Bates M, Carroll AP, Saffery R, Dean B. Decreased cortical muscarinic M1 receptors in schizophrenia are associated with changes in gene promoter methylation, mRNA and gene targeting microRNA. Transl Psychiatry. 2013 Feb 19;3(2):e230. doi: 10.1038/tp.2013.3.
PubMed 23423139
Scarr E, Hopper S, Vos V, Seo MS, Everall IP, Aumann TD, Chana G, Dean B. Low levels of muscarinic M1 receptor-positive neurons in cortical layers III and V in Brodmann areas 9 and 17 from individuals with schizophrenia. J Psychiatry Neurosci. 2018 Aug;43(5):338-346. doi: 10.1503/jpn.170202.
PubMed 30125244
Hopper S, Pavey GM, Gogos A, Dean B. Widespread Changes in Positive Allosteric Modulation of the Muscarinic M1 Receptor in Some Participants With Schizophrenia. Int J Neuropsychopharmacol. 2019 Oct 1;22(10):640-650. doi: 10.1093/ijnp/pyz045.
PubMed 31428788
Crook JM, Tomaskovic-Crook E, Copolov DL, Dean B. Decreased muscarinic receptor binding in subjects with schizophrenia: a study of the human hippocampal formation. Biol Psychiatry. 2000 Sep 1;48(5):381-8. doi: 10.1016/s0006-3223(00)00918-5.
PubMed 10978721
Lebois EP, Trimper JB, Hu C, Levey AI, Manns JR. Effects of Selective M1 Muscarinic Receptor Activation on Hippocampal Spatial Representations and Neuronal Oscillations. ACS Chem Neurosci. 2016 Oct 19;7(10):1393-1405. doi: 10.1021/acschemneuro.6b00160. Epub 2016 Aug 12.
PubMed 27479319
Harrison PJ. Using our brains: the findings, flaws, and future of postmortem studies of psychiatric disorders. Biol Psychiatry. 2011 Jan 15;69(2):102-3. doi: 10.1016/j.biopsych.2010.09.008. No abstract available.
PubMed 21183008
Nabulsi NB, Holden D, Zheng MQ, Bois F, Lin SF, Najafzadeh S, Gao H, Ropchan J, Lara-Jaime T, Labaree D, Shirali A, Slieker L, Jesudason C, Barth V, Navarro A, Kant N, Carson RE, Huang Y. Evaluation of 11C-LSN3172176 as a Novel PET Tracer for Imaging M1 Muscarinic Acetylcholine Receptors in Nonhuman Primates. J Nucl Med. 2019 Aug;60(8):1147-1153. doi: 10.2967/jnumed.118.222034. Epub 2019 Feb 7.
PubMed 30733324

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Muscarinic M1 Receptor Availability and Cognition in Schizophrenia
ClinicalTrials.gov ID: NCT05105542
Acronym / sponsor ID: 2000031171
Conditions: Schizophrenia, Schizoaffective Disorder, Healthy
Keywords: Schizophrenia, Muscarinic M1 Receptor, M1 AChR, [11C]EMO, PET Scan, MRI Scan
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 20 Apr 2021 (actual)
Primary completion: 31 Oct 2023 (actual)
Study completion: 31 Oct 2023 (actual)
First posted: 3 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Two groups will be studied: 1.) patients diagnosed with schizophrenia or schizoaffective disorder, and 2.) age and gender-matched healthy controls. Both groups will undergo neuroimaging, cognitive assessments, etc.

Arm	Type	Receives
Schizophrenia or schizoaffective disorder	Experimental	Drug: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor, Device: PET ScanParticipants will undergo a single PET scan with [11C]EMO ≤ 20 mCi
Healthy Controls	Experimental	Drug: 11C-EMO - A Novel PET Radiotracer for Muscarinic M1 Receptor, Device: PET ScanParticipants will undergo a single PET scan with [11C]EMO ≤ 20 mCi

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Men and women aged 18- 65 years that are physically and mentally healthy with the exception of DSM-5 schizophrenia or schizoaffective disorder diagnosis
Subjects with no metal in the body that may pose a risk during MRI scanning
No significant medical history, including head trauma and bleeding disorders

Key exclusion criteria (2 listed)

Men and women with a history or presence of clinically significant medical conditions
People who suffer from claustrophobia, have MRI incompatible implants, or other contraindications for MRI and PET scans

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
11C-EMO - A Novel PET Radiotracer for Muscarinic M1 ReceptorThe radiotracer, [11C]EMO, will be administered at the beginning of each PET scan.	Drug	Healthy Controls, Schizophrenia or schizoaffective disorder
PET ScanPET scanner with high sensitivity and resolution available for human brain imaging	Device	Healthy Controls, Schizophrenia or schizoaffective disorder

Primary outcome

Hippocampal M1 availability
Time frame: 10 days
Measured by [11C]EMO availability (BPND)

2 secondary outcomes

evoked ɣ oscillations
Time frame: 10 days
verbal memory
Time frame: 10 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Background: PubMed 29643252Mogg AJ, Eessalu T, Johnson M, Wright R, Sanger HE, Xiao H, Crabtree MG, Smith A, Colvin EM, Schober D, Gehlert D, Jesudason C, Goldsmith PJ, Johnson MP, Felder CC, Barth VN, Broad LM. In Vitro Pharmacological Characterization and In Vivo Validation of LSN3172176 a Novel M1 Selective Muscarinic Receptor Agonist Tracer Molecule for Positron Emission Tomography. J Pharmacol Exp Ther. 2018 Jun;365(3):602-613. doi: 10.1124/jpet.117.246454. Epub 2018 Apr 11.
Background: PubMed 15661360Oki T, Takagi Y, Inagaki S, Taketo MM, Manabe T, Matsui M, Yamada S. Quantitative analysis of binding parameters of [3H]N-methylscopolamine in central nervous system of muscarinic acetylcholine receptor knockout mice. Brain Res Mol Brain Res. 2005 Jan 5;133(1):6-11. doi: 10.1016/j.molbrainres.2004.09.012.
Background: PubMed 32201327Smart K, Gallezot JD, Nabulsi N, Labaree D, Zheng MQ, Huang Y, Carson RE, Hillmer AT, Worhunsky PD. Separating dopamine D2 and D3 receptor sources of [11C]-(+)-PHNO binding potential: Independent component analysis of competitive binding. Neuroimage. 2020 Jul 1;214:116762. doi: 10.1016/j.neuroimage.2020.116762. Epub 2020 Mar 19.
Background: PubMed 28110088Worhunsky PD, Matuskey D, Gallezot JD, Gaiser EC, Nabulsi N, Angarita GA, Calhoun VD, Malison RT, Potenza MN, Carson RE. Regional and source-based patterns of [11C]-(+)-PHNO binding potential reveal concurrent alterations in dopamine D2 and D3 receptor availability in cocaine-use disorder. Neuroimage. 2017 Mar 1;148:343-351. doi: 10.1016/j.neuroimage.2017.01.045. Epub 2017 Jan 19.
Background: PubMed 31505202Carruthers SP, Van Rheenen TE, Gurvich C, Sumner PJ, Rossell SL. Characterising the structure of cognitive heterogeneity in schizophrenia spectrum disorders. A systematic review and narrative synthesis. Neurosci Biobehav Rev. 2019 Dec;107:252-278. doi: 10.1016/j.neubiorev.2019.09.006. Epub 2019 Sep 7.
Background: PubMed 30285056Niendam TA, Ray KL, Iosif AM, Lesh TA, Ashby SR, Patel PK, Smucny J, Ferrer E, Solomon M, Ragland JD, Carter CS. Association of Age at Onset and Longitudinal Course of Prefrontal Function in Youth With Schizophrenia. JAMA Psychiatry. 2018 Dec 1;75(12):1252-1260. doi: 10.1001/jamapsychiatry.2018.2538.
Background: PubMed 28981831Van Rheenen TE, Cropley V, Zalesky A, Bousman C, Wells R, Bruggemann J, Sundram S, Weinberg D, Lenroot RK, Pereira A, Shannon Weickert C, Weickert TW, Pantelis C. Widespread Volumetric Reductions in Schizophrenia and Schizoaffective Patients Displaying Compromised Cognitive Abilities. Schizophr Bull. 2018 Apr 6;44(3):560-574. doi: 10.1093/schbul/sbx109.
Background: PubMed 27336046Wells R, Swaminathan V, Sundram S, Weinberg D, Bruggemann J, Jacomb I, Cropley V, Lenroot R, Pereira AM, Zalesky A, Bousman C, Pantelis C, Weickert CS, Weickert TW. The impact of premorbid and current intellect in schizophrenia: cognitive, symptom, and functional outcomes. NPJ Schizophr. 2015 Nov 4;1:15043. doi: 10.1038/npjschz.2015.43. eCollection 2015.
Background: PubMed 23423139Scarr E, Craig JM, Cairns MJ, Seo MS, Galati JC, Beveridge NJ, Gibbons A, Juzva S, Weinrich B, Parkinson-Bates M, Carroll AP, Saffery R, Dean B. Decreased cortical muscarinic M1 receptors in schizophrenia are associated with changes in gene promoter methylation, mRNA and gene targeting microRNA. Transl Psychiatry. 2013 Feb 19;3(2):e230. doi: 10.1038/tp.2013.3.
Background: PubMed 30125244Scarr E, Hopper S, Vos V, Seo MS, Everall IP, Aumann TD, Chana G, Dean B. Low levels of muscarinic M1 receptor-positive neurons in cortical layers III and V in Brodmann areas 9 and 17 from individuals with schizophrenia. J Psychiatry Neurosci. 2018 Aug;43(5):338-346. doi: 10.1503/jpn.170202.
Background: PubMed 31428788Hopper S, Pavey GM, Gogos A, Dean B. Widespread Changes in Positive Allosteric Modulation of the Muscarinic M1 Receptor in Some Participants With Schizophrenia. Int J Neuropsychopharmacol. 2019 Oct 1;22(10):640-650. doi: 10.1093/ijnp/pyz045.
Background: PubMed 10978721Crook JM, Tomaskovic-Crook E, Copolov DL, Dean B. Decreased muscarinic receptor binding in subjects with schizophrenia: a study of the human hippocampal formation. Biol Psychiatry. 2000 Sep 1;48(5):381-8. doi: 10.1016/s0006-3223(00)00918-5.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rajiv Radhakrishnan, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hippocampal M1 availability (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05105542, which also lists 58 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.