Parkinson's DiseaseNCT05034263
Imaging a Cholinergic Biomarker of Cognition in Parkinson's Disease
An observational study of Parkinson's Disease, run by Stony Brook University at 1 site in United States.
Trial summary
This is an imaging study designed to illuminate the function of the cholinergic system and its association with cognitive skills in people with Parkinson's disease. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 27 May 2024
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Parkinson's disease who have normal cognition or mild cognitive impairment
Who may be able to join
- Age 50-80
- Diagnosis of Parkinson's disease
- Ability to provide informed consent
- Ability to speak English
- Normal cognition or mild cognitive impairment
- Willingness to go off parkinsonian medication for 12 hours prior to two of the study visits
Who cannot join
- Contraindication for MRI
- Abnormal clinical brain MRI, specifically with evidence of large-vessel stroke or mass lesion
- History of stereotactic or ablative brain surgery
- Pregnancy
- Recent participation in other research studies involving radiation such that the annual research radiation dose would exceed FDA Limit if participating in this study
- Prior brain injury (eg., TBI)
Show all 10Show fewer
- Baseline cognitive impairment due to genetic or developmental disorder
- Active illicit drug use or alcohol abuse
- Incapable of staying still for a 2-hour PET or MRI study
- Use of CNS-penetrating medications affecting the cholinergic system, including cholinesterase inhibitors and anticholinergics, up to 60 days prior to study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook Medical Center
Stony Brook, New York, 11794
About this study
This is an imaging study designed to illuminate the function of the cholinergic system and its association with cognitive skills in people with Parkinson's disease. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. Participants will receive a PET and MRI scan along with a battery of neurocognitive tests at baseline and again at 18 months follow-up. Hormone levels will be measured at baseline.
Read the detailed description
This is an imaging study designed to illuminate the functioning of the cholinergic system in people with Parkinson's disease. Some people with Parkinson's disease develop trouble with certain aspects of thinking such as memory. Studies have shown an association between a decline in thinking skills and dysfunction of the cholinergic system. This study will use the novel PET tracer [18F]VAT to provide more specific information about how the cholinergic system works by enabling direct measurement of cholinergic terminal density and projections. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. This is a longitudinal observational study that involves a screening visit and four study visits over the course of 18 months. The visits consist of neurocognitive assessments and imaging (MRI and PET scans) administered at baseline and at 18 months follow-up. Hormone levels will also be measured at baseline. This study is open to people with Parkinson's disease who have either normal cognition or mild cognitive impairment.
- Conditions
- Parkinson's Disease
- Keywords
- Acetylcholine, PET, MRI
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholinergic terminal density at baseline
Measured by PET scan 18F[VAT] distribution volume
Measured: Baseline
Cholinergic terminal density change between baseline and 18-months follow-up
Measured by the difference in PET scan 18F[VAT] distribution volume at baseline and 18-months follow-up
Measured: Baseline and 18 months follow-up
Overall cognitive functioning at baseline
As measured by the Montreal Cognitive Assessment (MoCA). The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Measured: Baseline
Change in overall cognitive functioning
As measured by the difference between the Montreal Cognitive Assessment (MoCA) score at baseline and at 18-months follow-up.The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Measured: Baseline and 18 Months
Attention/working memory at baseline as measured by the Trail Making A Test
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
Measured: Baseline
Attention/working memory change from baseline to 18-months follow-up as measured by the Trail Making A Test
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
Measured: 18 months
Attention/working memory at baseline as measured by the Symbol Digit Modalities Test (SDMT)
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Measured: Baseline
Attention/working memory change from baseline to 18-months follow-up as measured by the Symbol Digit Modalities Test
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Measured: Baseline and 18- months follow-up
Executive function at baseline as measured by the Clock Drawing Test
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Measured: Baseline
Executive function change from baseline to 18-months follow-up as measured by the Clock Drawing Test
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Measured: Baseline and 18-month follow-up
Executive function at baseline as measured by the Trail Making Test B
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Measured: Baseline
Executive function change from baseline to 18-months follow-up as measured by the Trail Making Test B
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Measured: Baseline and 18-month follow-up
Language at baseline as measured by the Animal Naming Test
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Measured: Baseline
Language change from baseline to 18-month follow-up as measured by the Animal Naming Test
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Measured: Baseline and 18-months follow-up
Language at baseline as measured by the Boston Naming Test
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Measured: Baseline
Language change from baseline to 18-months follow-up as measured by the Boston Naming Test
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Measured: Baseline and 18-months follow-up
Language change between baseline and 18-month follow-up as measured by the Boston Naming Test
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Measured: Baseline
Memory at baseline as measured by the Free and Cued Selective Reminding Test
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Measured: Baseline
Memory change from baseline to 18-months follow-up as measured by the Free and Cued Selective Reminding Test
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Measured: Baseline and 18-months follow-up
Memory at baseline as measured by the Brief Visuospatial Memory Test-Revised Selective Reminding Test
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Measured: Baseline
Memory change from baseline to 18-months follow-up as measured by the Brief Visuospatial Memory Test-Revised
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Measured: Baseline and 18-months follow-up
Memory change between baseline and 18-month follow-up
As measured by the change in Free and Cued Selective Reminding Test and the Brief Visuospatial Memory Test-Revised scores at baseline and at 18-months follow-up.
Measured: Baseline and 18-month follow-up
Visuospatial at baseline as measured by the Judgement of Line Orientation Test
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Measured: Baseline
Visuospatial change from baseline to 18-months follow-up as measured by the Judgement of Line Orientation Test
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Measured: Baseline and 18-months follow-up
Visuospatial at baseline as measured by the Intersecting Pentagons Test
Intersecting Pentagons is a measure of visuospatial sense that takes less than 5 minutes to administer.
Measured: Baseline
Visuospatial change from baseline to 18-months follow-up as measured by the Intersecting Pentagons Test
Intersecting Pentagons is a measure of visuospatial perception that takes less than 5 minutes to administer.
Measured: Baseline and 18-months follow-up
Estrogen levels in blood at baseline
Estrogen levels (picograms of estradiol per milliliter of serum) will be measured via blood draw performed at baseline
Measured: Baseline
Progesterone levels in blood as baseline
Progesterone levels (nanograms of progesterone per milliliter of serum) will be measured via blood draw at baseline
Measured: Baseline
Testosterone levels in blood at baseline
Levels of free testosterone (picograms testosterone per milliliter serum) and total testosterone (nanograms testosterone/deciliter serum) will be measured via blood draw performed at the baseline visit.
Measured: Baseline
Secondary outcomes (6)
Cholinergic terminal binding potential at baseline
Measured by PFC [18F]VAT VT and BPND
Measured: Baseline
Cholinergic terminal binding potential change between baseline and 18-months follow-up
Measured by PFC [18F]VAT VT and BPND
Measured: Baseline and 18-month follow-up
MRI Fractional anisotropy (FA) Values at baseline
As measured by fMRI at baseline
Measured: Baseline
Change in MRI Fractional anisotropy (FA) Values from baseline to 18-months follow-up
As measured by fMRI at baseline and 18-months follow-up
Measured: Baseline and 18-months follow-up
MRI Resting-state functional connectivity at baseline
As measured by fMRI
Measured: Baseline
MRI Resting-state functional connectivity change between baseline and 18-months follow-up
As measured by fMRI
Measured: Baseline and 18-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start27 May 2021
- Primary completion27 May 2024
- Study completion27 May 2024
Why it stopped: Discontinuation of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Principal investigator, Chuan Huang, Stony Brook University
- Investigators
- Chuan Huang, PhD, Principal investigator, Stony Brook Medical CenterCarine Maurer, PhD, Principal investigator, Stony Brook Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034263
- Sponsor's protocol ID
- 2020-00669
- Status last verified
- Apr 2025
- First submitted
- 17 Aug 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging a Cholinergic Biomarker of Cognition in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05034263
- Acronym / sponsor ID
- 2020-00669
- Conditions
- Parkinson's Disease
- Keywords
- Acetylcholine, PET, MRI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Discontinuation of funding.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 27 May 2021 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 5 Sep 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.
This is an imaging study designed to illuminate the function of the cholinergic system and its association with cognitive skills in people with Parkinson's disease. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. Participants will receive a PET and MRI scan along with a battery of neurocognitive tests at baseline and again at 18 months follow-up. Hormone levels will be measured at baseline.
Detailed description
This is an imaging study designed to illuminate the functioning of the cholinergic system in people with Parkinson's disease. Some people with Parkinson's disease develop trouble with certain aspects of thinking such as memory. Studies have shown an association between a decline in thinking skills and dysfunction of the cholinergic system. This study will use the novel PET tracer [18F]VAT to provide more specific information about how the cholinergic system works by enabling direct measurement of cholinergic terminal density and projections. The hypothesis of this study is that there will be an association between cholinergic terminal density, sex hormones, and cognitive functioning. This is a longitudinal observational study that involves a screening visit and four study visits over the course of 18 months. The visits consist of neurocognitive assessments and imaging (MRI and PET scans) administered at baseline and at 18 months follow-up. Hormone levels will also be measured at baseline. This study is open to people with Parkinson's disease who have either normal cognition or mild cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Parkinson's disease who have normal cognition or mild cognitive impairment
Key inclusion criteria (6 listed)
- Age 50-80
- Diagnosis of Parkinson's disease
- Ability to provide informed consent
- Ability to speak English
- Normal cognition or mild cognitive impairment
Key exclusion criteria (10 listed)
- Contraindication for MRI
- Abnormal clinical brain MRI, specifically with evidence of large-vessel stroke or mass lesion
- History of stereotactic or ablative brain surgery
- Pregnancy
- Recent participation in other research studies involving radiation such that the annual research radiation dose would exceed FDA Limit if participating in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cholinergic terminal density at baseline
Time frame: Baseline
Measured by PET scan 18F[VAT] distribution volume
Cholinergic terminal density change between baseline and 18-months follow-up
Time frame: Baseline and 18 months follow-up
Measured by the difference in PET scan 18F[VAT] distribution volume at baseline and 18-months follow-up
Overall cognitive functioning at baseline
Time frame: Baseline
As measured by the Montreal Cognitive Assessment (MoCA). The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Change in overall cognitive functioning
Time frame: Baseline and 18 Months
As measured by the difference between the Montreal Cognitive Assessment (MoCA) score at baseline and at 18-months follow-up.The MoCA measures eight domains commonly affected by mild cognitive impairment. The one-page 30-point test includes assessments of short-term and delayed memory recall, visuospatial abilities, language, orientation to time and space, and executive functions including attention, concentration, and working memory. The MoCA has been shown to be sensitive to change over time. Scores on the MocA range from 0-30 with higher scores indicating better cognitive functioning.
Attention/working memory at baseline as measured by the Trail Making A Test
Time frame: Baseline
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
Attention/working memory change from baseline to 18-months follow-up as measured by the Trail Making A Test
Time frame: 18 months
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test A is 5 minutes.
Attention/working memory at baseline as measured by the Symbol Digit Modalities Test (SDMT)
Time frame: Baseline
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Attention/working memory change from baseline to 18-months follow-up as measured by the Symbol Digit Modalities Test
Time frame: Baseline and 18- months follow-up
Symbol Digit Modalities Test (SDMT) takes five minutes to complete and has demonstrated sensitivity in detecting changes in cognitive functioning over time.
Executive function at baseline as measured by the Clock Drawing Test
Time frame: Baseline
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Executive function change from baseline to 18-months follow-up as measured by the Clock Drawing Test
Time frame: Baseline and 18-month follow-up
The Clock Drawing Test is a quick screening test for cognitive dysfunction secondary to a range of neurological disorders and takes less than 5 minutes to administer.
Executive function at baseline as measured by the Trail Making Test B
Time frame: Baseline
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Executive function change from baseline to 18-months follow-up as measured by the Trail Making Test B
Time frame: Baseline and 18-month follow-up
The Trail Making Test is a quickly and easily administered test which assesses cognitive abilities such as visual-conceptual and visual-motor tracking, sustained attention, and task alternation abilities. Administration time for the Trail Making Test B is 10 minutes.
Language at baseline as measured by the Animal Naming Test
Time frame: Baseline
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Language change from baseline to 18-month follow-up as measured by the Animal Naming Test
Time frame: Baseline and 18-months follow-up
The Animal Naming Test is a semantic fluency test that takes one minute to administer.
Language at baseline as measured by the Boston Naming Test
Time frame: Baseline
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Language change from baseline to 18-months follow-up as measured by the Boston Naming Test
Time frame: Baseline and 18-months follow-up
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Language change between baseline and 18-month follow-up as measured by the Boston Naming Test
Time frame: Baseline
The Boston Naming Test measures confrontational word retrieval and takes about 15 minutes to administer.
Memory at baseline as measured by the Free and Cued Selective Reminding Test
Time frame: Baseline
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Memory change from baseline to 18-months follow-up as measured by the Free and Cued Selective Reminding Test
Time frame: Baseline and 18-months follow-up
The Free and Cued Selective Reminding Test is an episodic memory test which assesses immediate and delayed free and cued-facilitated recall.
Memory at baseline as measured by the Brief Visuospatial Memory Test-Revised Selective Reminding Test
Time frame: Baseline
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Memory change from baseline to 18-months follow-up as measured by the Brief Visuospatial Memory Test-Revised
Time frame: Baseline and 18-months follow-up
The Brief Visuospatial Memory Test-Revised is a brief measure of visuospatial memory that takes approximately 45 minutes to administer.
Memory change between baseline and 18-month follow-up
Time frame: Baseline and 18-month follow-up
As measured by the change in Free and Cued Selective Reminding Test and the Brief Visuospatial Memory Test-Revised scores at baseline and at 18-months follow-up.
Visuospatial at baseline as measured by the Judgement of Line Orientation Test
Time frame: Baseline
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Visuospatial change from baseline to 18-months follow-up as measured by the Judgement of Line Orientation Test
Time frame: Baseline and 18-months follow-up
Judgement of Line Orientation measures visuospatial perception and takes less than 15 minutes to administer.
Visuospatial at baseline as measured by the Intersecting Pentagons Test
Time frame: Baseline
Intersecting Pentagons is a measure of visuospatial sense that takes less than 5 minutes to administer.
Visuospatial change from baseline to 18-months follow-up as measured by the Intersecting Pentagons Test
Time frame: Baseline and 18-months follow-up
Intersecting Pentagons is a measure of visuospatial perception that takes less than 5 minutes to administer.
Estrogen levels in blood at baseline
Time frame: Baseline
Estrogen levels (picograms of estradiol per milliliter of serum) will be measured via blood draw performed at baseline
Progesterone levels in blood as baseline
Time frame: Baseline
Progesterone levels (nanograms of progesterone per milliliter of serum) will be measured via blood draw at baseline
Testosterone levels in blood at baseline
Time frame: Baseline
Levels of free testosterone (picograms testosterone per milliliter serum) and total testosterone (nanograms testosterone/deciliter serum) will be measured via blood draw performed at the baseline visit.
6 secondary outcomes
Cholinergic terminal binding potential at baseline
Time frame: Baseline
Cholinergic terminal binding potential change between baseline and 18-months follow-up
Time frame: Baseline and 18-month follow-up
MRI Fractional anisotropy (FA) Values at baseline
Time frame: Baseline
Change in MRI Fractional anisotropy (FA) Values from baseline to 18-months follow-up
Time frame: Baseline and 18-months follow-up
MRI Resting-state functional connectivity at baseline
Time frame: Baseline
MRI Resting-state functional connectivity change between baseline and 18-months follow-up
Time frame: Baseline and 18-months follow-up
Results and safety
The study was stopped early (reason given: Discontinuation of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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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.
Chuan Huang, PhD principal investigator
Stony Brook Medical Center
Carine Maurer, PhD principal investigator
Stony Brook Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Stony Brook University at 1 site in United States.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 6 Apr 2025. 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.
Are results available for this study?
The study was stopped early (reason given: Discontinuation of funding.). Results are not available in the source record.
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?
Cholinergic terminal density at baseline (time frame: Baseline). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.