Mild Cognitive ImpairmentIMPACTNCT02778971
Implications for Management of PET Amyloid Classification Technology
An observational study of Mild Cognitive Impairment and Dementia, run by University of Utah at 1 site in United States.
Trial summary
The main purpose of this study is to explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Alzheimer's Disease
- What is being tested?
- [18F]Flutemetamol
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 2022
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants: Adults 45-90 years of age with a confirmed diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
Who may be able to join
- Patients must be 45 to 90 years of age for inclusion in this research study.
- Confirmed diagnosis of MCI or dementia of unclear etiology, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
- Meets Appropriate Use Criteria (AUC)
- Cognitive complaint verified by objectively confirmed cognitive impairment;
- The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging as below;
- Alzheimer's disease is a diagnostic consideration;
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- Knowledge of amyloid PET status is expected to alter diagnosis and management.
- MRI and/or CT of the brain within 12 months prior to enrollment;
- Clinical laboratory assessment within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH), vitamin B12;
- Patient must agree to have clinical and radiographic endpoints and the results of and other laboratory information entered into a research database, as evidenced by signing the informed consent form.
- Patient must be postmenopausal for a minimum of one year, surgically sterile, or has been confirmed not to be pregnant by serum pregnancy test performed within 24 hours prior to research PET imaging.
- All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
Who cannot join
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo PET imaging.
- Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening.
- Patients with Normal cognition or subjective complaints that are not verified by cognitive testing.
- Subject's scans being ordered for one of the following reasons:
Show all 10Show fewer
- Scan is being ordered solely based on a family history of dementia, presence of apolipoprotein E, or in lieu of genotyping for suspected autosomal mutation carriers;
- Scan being ordered for nonmedical purposes (e.g., legal, insurance coverage, or employment screening)
- Currently pregnant
- Patients who are unwilling to know the results of their PET imaging scan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Alzheimer's Care, Imaging & Research
Salt Lake City, Utah, 84108-1225
About this study
The main purpose of this study is to explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. This study also intends to capture specific patient-reported outcomes related to patient burden, confidence and satisfaction.
The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
Read the detailed description
The primary purpose of this prospective, observational study is to examine the benefit of [18F]Flutemetamol PET/CT scan in clinical practice for early diagnosis of cognitive impairment and identifying Alzheimer's disease (AD) pathology. To accomplish this, when a clinician has ordered an amyloid positron emission tomography (PET) scan, the investigators will assess the impact of [18F]Flutemetamol PET/CT scans on 1) physician diagnosis and management as it relates to care practices and drug management, and 2) patient reported outcomes in patients evaluated in the Cognitive Disorders Clinic at the University of Utah and meeting Appropriate Use Criteria (AUC) for clinical amyloid PET/CT scans. A secondary purpose is to compare the semi-quantitative assessment of amyloid plaque burden using vendor supplied software and standard visual assessment of amyloid positivity.
The primary hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET/CT scans may alter patient diagnosis and management and lead to significant changes in patient and family reported outcomes. A secondary hypothesis is that vendor supplied semi-quantitative assessment of amyloid plaque positivity will be superior to standard visual criteria assessments.
Aims:
Aim 1: To assess the change in diagnosis and management including both care practices and drug management of adult patients being evaluated for cognitive deficits and meeting Appropriate Use Criteria (AUC).
Aim 2: To assess the change of amyloid PET/CT scans on patient-reported outcomes involving care partner confidence and satisfaction.
Aim 3: To assess the confidence of visual interpretation by using vendor supplied semi-quantitative software to assess amyloid plaque burden.
Hypotheses to be Tested - Synopsis The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
Aim 1
- Amyloid PET will change physician judgment of the likelihood of AD
- Amyloid PET will change the leading diagnosis in more than 25% of cases
- Amyloid PET will increase physician diagnostic confidence in the leading diagnosis
- Amyloid PET will change more than 25% of care practice options from pre-scan management
- Amyloid PET will change more than 25% of drug management options
Aim 2
- Care partners are more confident in the diagnosis after the scan than before the scan
- Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation than previous evaluation
- Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation with amyloid PET than than the evaluation non-specialists performed without amyloid PET
- Care partners will find amyloid PET not very burdensome if the doctor finds a scan helpful
- Based upon their experience with the amyloid PET scan, a majority of the care partners would still agree to have an amyloid PET scan performed if it were requested by the specialist
- Care partners will find that amyloid PET did not cause an increase in adverse reactions (scan visit) than standard routine clinic visit (post-scan visit)
- Care partners will find that the diagnostic clinic visit (post-scan visit) did not cause an increase in adverse reactions than the first clinic visit (pre-scan visit)
Aim 3:
- Confidence of radiologist / nuclear medicine physician interpretation of scans increases after adding quantitative analysis as compared to qualitative analysis alone
This study will use [18F]Flutemetamol-PET imaging to assess and quantify the amyloid plaque burden in patients with mild cognitive impairment (MCI) or dementia of unclear etiology, according to Diagnostic Statistical Manual-IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
The [18F]Flutemetamol-PET scans of these study participants will then be assessed using a General Electric (GE) software databases (NeuroMarQ) which contain scan data from healthy control individuals to evaluate for abnormalities in amyloid plaque burden differing from the values expected for individuals in their age range.
- Conditions
- Mild Cognitive Impairment, Dementia, Alzheimer's Disease
- Being tested
- [18F]Flutemetamol
- Keywords
- MCI, Dementia, amyloid PET, physician diagnosis, Alzheimer's disease, AD, PET imaging, Appropriate Use Criteria, patient-reported outcomes
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FlutemetamolDrug
Also called Vizamyl
amyloid PET imaging with [18F]Flutemetamol and subsequent modification of diagnosis and management
| Study group | Role | What they receive |
|---|---|---|
| Qualifying participants | All consented participants referred by a dementia expert physician to receive an amyloid PET scan with [18F]Flutametamol and meeting eligibility criteria will have visual and semi-quantitative software aided scan interpretation, complete care partner questionnaires and providers will document diagnosis, diagnostic confidence, and management plan before and after the scan. Receives: Drug: [18F]Flutemetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of care practices changed after amyloid PET scan
% of 13 care practices that differ before and after the amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Secondary outcomes (12)
Proportion of drug management options changed after amyloid PET
% of drug management options that differ before and after the amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in % likelihood of Alzheimer's disease (AD) diagnosis after amyloid PET scan
Difference in % of AD likelihood identified before and after the amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Proportion of change in leading diagnosis after amyloid PET
% of leading diagnosis that differ before and after amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in physician confidence in leading diagnosis
Difference in a 5-point scale of physician confidence in leading diagnosis before and after amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner's confidence in diagnosis after amyloid PET
Difference in a 5-point scale of care partner confidence in diagnosis before and after amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner satisfaction with evaluation after amyloid PET
Difference in a 5-point scale of care partner satisfaction before team care and after amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner assessment of the quality of evaluation after amyloid PET
Difference in a 5-point scale of care partner quality before team care and after amyloid PET scan
Measured: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Proportion of care partners finding amyloid PET scan worthwhile
Proportion of care partners indicating they would agree to do an amyloid PET again on a yes/no/don't know scale
Measured: Visit 4, 90 days after scan
Proportion exhibiting increased behavior disturbance during amyloid scan visit
% of patients showing a difference in the 44-point Catastrophic Reaction Scale between the median value in all non-scan visits and the value in the amyloid PET scan visit
Measured: at each visit, visits1-4, 120 days
Proportion exhibiting increased behavior disturbance when the diagnosis is given
% of patients showing a difference in the 44-point Catastrophic Reaction Scale between Visit 1 and Visit 3 when learning the result of the scan
Measured: Visit 1, Visit 3, 60 days
Percentage of recommended care practices adhered to after amyloid PET scan
% of care practices recommended after amyloid PET scan reported by care partner
Measured: Visit 4 90 days post scan
Percentage of recommended drug management adhered to after amyloid PET scan
% of drug management options recommended after amyloid PET scan reported by care partner
Measured: Visit 4 90 days post scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionSep 2022
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 Mild Cognitive ImpairmentStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norman L. Foster, M.D., Principal investigator, Director: Center for Alzheimer's Care, Imaging & Research; Chief: Division of Cognitive Neurology; Senior Investigator: The Brain Institute; Professor: Dept. of Neurology University of Utah School of MedicineJohn M. Hoffman, M.D., Principal investigator, Professor of Radiology and Neurology Director of Nuclear Medicine; Director: Center for Quantitative Cancer Imaging Huntsman Cancer Institute University of Utah School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778971
- Sponsor's protocol ID
- 00084919
- Acronym
- IMPACT
- Status last verified
- Jan 2020
- First submitted
- 6 May 2016
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Naylor MD, Karlawish JH, Arnold SE, Khachaturian AS, Khachaturian ZS, Lee VM, Baumgart M, Banerjee S, Beck C, Blennow K, Brookmeyer R, Brunden KR, Buckwalter KC, Comer M, Covinsky K, Feinberg LF, Frisoni G, Green C, Guimaraes RM, Gwyther LP, Hefti FF, Hutton M, Kawas C, Kent DM, Kuller L, Langa KM, Mahley RW, Maslow K, Masters CL, Meier DE, Neumann PJ, Paul SM, Petersen RC, Sager MA, Sano M, Schenk D, Soares H, Sperling RA, Stahl SM, van Deerlin V, Stern Y, Weir D, Wolk DA, Trojanowski JQ. Advancing Alzheimer's disease diagnosis, treatment, and care: recommendations from the Ware Invitational Summit. Alzheimers Dement. 2012 Sep;8(5):445-52. doi: 10.1016/j.jalz.2012.08.001.
PubMed 22959699Albert MS, Blacker D. Mild cognitive impairment and dementia. Annu Rev Clin Psychol. 2006;2:379-88. doi: 10.1146/annurev.clinpsy.1.102803.144039.
PubMed 17716075Mitchell AJ. The clinical significance of subjective memory complaints in the diagnosis of mild cognitive impairment and dementia: a meta-analysis. Int J Geriatr Psychiatry. 2008 Nov;23(11):1191-202. doi: 10.1002/gps.2053.
PubMed 18500688Matsuda T, Takayama T, Tashiro M, Nakamura Y, Ohashi Y, Shimozuma K. Mild cognitive impairment after adjuvant chemotherapy in breast cancer patients--evaluation of appropriate research design and methodology to measure symptoms. Breast Cancer. 2005;12(4):279-87. doi: 10.2325/jbcs.12.279.
PubMed 16286908Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.
PubMed 10190820Braak H, Braak E. Diagnostic criteria for neuropathologic assessment of Alzheimer's disease. Neurobiol Aging. 1997 Jul-Aug;18(4 Suppl):S85-8. doi: 10.1016/s0197-4580(97)00062-6.
PubMed 9330992Selkoe DJ. Physiological production of the beta-amyloid protein and the mechanism of Alzheimer's disease. Trends Neurosci. 1993 Oct;16(10):403-9. doi: 10.1016/0166-2236(93)90008-a.
PubMed 7504355Naslund J, Haroutunian V, Mohs R, Davis KL, Davies P, Greengard P, Buxbaum JD. Correlation between elevated levels of amyloid beta-peptide in the brain and cognitive decline. JAMA. 2000 Mar 22-29;283(12):1571-7. doi: 10.1001/jama.283.12.1571.
PubMed 10735393Arendash GW, Gordon MN, Diamond DM, Austin LA, Hatcher JM, Jantzen P, DiCarlo G, Wilcock D, Morgan D. Behavioral assessment of Alzheimer's transgenic mice following long-term Abeta vaccination: task specificity and correlations between Abeta deposition and spatial memory. DNA Cell Biol. 2001 Nov;20(11):737-44. doi: 10.1089/10445490152717604.
PubMed 11788052Mosconi L, McHugh PF. FDG- and amyloid-PET in Alzheimer's disease: is the whole greater than the sum of the parts? Q J Nucl Med Mol Imaging. 2011 Jun;55(3):250-64.
PubMed 21532539Okello A, Koivunen J, Edison P, Archer HA, Turkheimer FE, Nagren K, Bullock R, Walker Z, Kennedy A, Fox NC, Rossor MN, Rinne JO, Brooks DJ. Conversion of amyloid positive and negative MCI to AD over 3 years: an 11C-PIB PET study. Neurology. 2009 Sep 8;73(10):754-60. doi: 10.1212/WNL.0b013e3181b23564. Epub 2009 Jul 8.
PubMed 19587325Resnick SM, Sojkova J, Zhou Y, An Y, Ye W, Holt DP, Dannals RF, Mathis CA, Klunk WE, Ferrucci L, Kraut MA, Wong DF. Longitudinal cognitive decline is associated with fibrillar amyloid-beta measured by [11C]PiB. Neurology. 2010 Mar 9;74(10):807-15. doi: 10.1212/WNL.0b013e3181d3e3e9. Epub 2010 Feb 10.
PubMed 20147655Wolk DA, Price JC, Saxton JA, Snitz BE, James JA, Lopez OL, Aizenstein HJ, Cohen AD, Weissfeld LA, Mathis CA, Klunk WE, De-Kosky ST. Amyloid imaging in mild cognitive impairment subtypes. Ann Neurol. 2009 May;65(5):557-68. doi: 10.1002/ana.21598.
PubMed 19475670Jack CR Jr, Knopman DS, Jagust WJ, Shaw LM, Aisen PS, Weiner MW, Petersen RC, Trojanowski JQ. Hypothetical model of dynamic biomarkers of the Alzheimer's pathological cascade. Lancet Neurol. 2010 Jan;9(1):119-28. doi: 10.1016/S1474-4422(09)70299-6.
PubMed 20083042Rowe CC, Villemagne VL. Amyloid imaging with PET in early Alzheimer disease diagnosis. Med Clin North Am. 2013 May;97(3):377-98. doi: 10.1016/j.mcna.2012.12.017.
PubMed 23642577
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications for Management of PET Amyloid Classification Technology
- ClinicalTrials.gov ID
- NCT02778971
- Acronym / sponsor ID
- IMPACT / 00084919
- Conditions
- Mild Cognitive Impairment, Dementia, Alzheimer's Disease
- Keywords
- MCI, Dementia, amyloid PET, physician diagnosis, Alzheimer's disease, AD, PET imaging, Appropriate Use Criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 20 May 2016 (estimated)
- 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.
The main purpose of this study is to explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. This study also intends to capture specific patient-reported outcomes related to patient burden, confidence and satisfaction.
The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
Detailed description
The primary purpose of this prospective, observational study is to examine the benefit of [18F]Flutemetamol PET/CT scan in clinical practice for early diagnosis of cognitive impairment and identifying Alzheimer's disease (AD) pathology. To accomplish this, when a clinician has ordered an amyloid positron emission tomography (PET) scan, the investigators will assess the impact of [18F]Flutemetamol PET/CT scans on 1) physician diagnosis and management as it relates to care practices and drug management, and 2) patient reported outcomes in patients evaluated in the Cognitive Disorders Clinic at the University of Utah and meeting Appropriate Use Criteria (AUC) for clinical amyloid PET/CT scans. A secondary purpose is to compare the semi-quantitative assessment of amyloid plaque burden using vendor supplied software and standard visual assessment of amyloid positivity.
The primary hypothesis is that, in diagnostically uncertain cases, knowledge of amyloid status as determined by amyloid PET/CT scans may alter patient diagnosis and management and lead to significant changes in patient and family reported outcomes. A secondary hypothesis is that vendor supplied semi-quantitative assessment of amyloid plaque positivity will be superior to standard visual criteria assessments.
Aims:
Aim 1: To assess the change in diagnosis and management including both care practices and drug management of adult patients being evaluated for cognitive deficits and meeting Appropriate Use Criteria (AUC).
Aim 2: To assess the change of amyloid PET/CT scans on patient-reported outcomes involving care partner confidence and satisfaction.
Aim 3: To assess the confidence of visual interpretation by using vendor supplied semi-quantitative software to assess amyloid plaque burden.
Hypotheses to be Tested - Synopsis The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
Aim 1
- Amyloid PET will change physician judgment of the likelihood of AD
- Amyloid PET will change the leading diagnosis in more than 25% of cases
- Amyloid PET will increase physician diagnostic confidence in the leading diagnosis
- Amyloid PET will change more than 25% of care practice options from pre-scan management
- Amyloid PET will change more than 25% of drug management options
Aim 2
- Care partners are more confident in the diagnosis after the scan than before the scan
- Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation than previous evaluation
- Care partners will be more satisfied with multidisciplinary cognitive specialty team evaluation with amyloid PET than than the evaluation non-specialists performed without amyloid PET
- Care partners will find amyloid PET not very burdensome if the doctor finds a scan helpful
- Based upon their experience with the amyloid PET scan, a majority of the care partners would still agree to have an amyloid PET scan performed if it were requested by the specialist
- Care partners will find that amyloid PET did not cause an increase in adverse reactions (scan visit) than standard routine clinic visit (post-scan visit)
- Care partners will find that the diagnostic clinic visit (post-scan visit) did not cause an increase in adverse reactions than the first clinic visit (pre-scan visit)
Aim 3:
- Confidence of radiologist / nuclear medicine physician interpretation of scans increases after adding quantitative analysis as compared to qualitative analysis alone
This study will use [18F]Flutemetamol-PET imaging to assess and quantify the amyloid plaque burden in patients with mild cognitive impairment (MCI) or dementia of unclear etiology, according to Diagnostic Statistical Manual-IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
The [18F]Flutemetamol-PET scans of these study participants will then be assessed using a General Electric (GE) software databases (NeuroMarQ) which contain scan data from healthy control individuals to evaluate for abnormalities in amyloid plaque burden differing from the values expected for individuals in their age range.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualifying participants | – | Drug: [18F]FlutemetamolAll consented participants referred by a dementia expert physician to receive an amyloid PET scan with [18F]Flutametamol and meeting eligibility criteria will have visual and semi-quantitative software aided scan interpretation, complete care partner questionnaires and providers will document diagnosis, diagnostic confidence, and management plan before and after the scan. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants: Adults 45-90 years of age with a confirmed diagnosis of MCI or dementia, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
Key inclusion criteria (12 listed)
- Patients must be 45 to 90 years of age for inclusion in this research study.
- Confirmed diagnosis of MCI or dementia of unclear etiology, according to DSM-IV and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months.
- Meets Appropriate Use Criteria (AUC)
- MRI and/or CT of the brain within 12 months prior to enrollment;
- Clinical laboratory assessment within the 12 months prior to enrollment: complete blood count (CBC), standard blood chemistry profile, thyroid stimulating hormone (TSH), vitamin B12;
Key exclusion criteria (10 listed)
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
- Adult patients who require monitored anesthesia for PET scanning.
- Patients who are too claustrophobic to undergo PET imaging.
- Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening.
- Patients with Normal cognition or subjective complaints that are not verified by cognitive testing.
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 |
|---|---|---|
| [18F]FlutemetamolAlso: Vizamylamyloid PET imaging with [18F]Flutemetamol and subsequent modification of diagnosis and management | Drug | Qualifying participants |
Primary outcome
Proportion of care practices changed after amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
% of 13 care practices that differ before and after the amyloid PET scan
12 secondary outcomes
Proportion of drug management options changed after amyloid PET
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in % likelihood of Alzheimer's disease (AD) diagnosis after amyloid PET scan
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Proportion of change in leading diagnosis after amyloid PET
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in physician confidence in leading diagnosis
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner's confidence in diagnosis after amyloid PET
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner satisfaction with evaluation after amyloid PET
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Change in care partner assessment of the quality of evaluation after amyloid PET
Time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan
Proportion of care partners finding amyloid PET scan worthwhile
Time frame: Visit 4, 90 days after scan
Proportion exhibiting increased behavior disturbance during amyloid scan visit
Time frame: at each visit, visits1-4, 120 days
Proportion exhibiting increased behavior disturbance when the diagnosis is given
Time frame: Visit 1, Visit 3, 60 days
Percentage of recommended care practices adhered to after amyloid PET scan
Time frame: Visit 4 90 days post scan
Percentage of recommended drug management adhered to after amyloid PET scan
Time frame: Visit 4 90 days post scan
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 24 Apr 2023.
- Background: PubMed 22959699Naylor MD, Karlawish JH, Arnold SE, Khachaturian AS, Khachaturian ZS, Lee VM, Baumgart M, Banerjee S, Beck C, Blennow K, Brookmeyer R, Brunden KR, Buckwalter KC, Comer M, Covinsky K, Feinberg LF, Frisoni G, Green C, Guimaraes RM, Gwyther LP, Hefti FF, Hutton M, Kawas C, Kent DM, Kuller L, Langa KM, Mahley RW, Maslow K, Masters CL, Meier DE, Neumann PJ, Paul SM, Petersen RC, Sager MA, Sano M, Schenk D, Soares H, Sperling RA, Stahl SM, van Deerlin V, Stern Y, Weir D, Wolk DA, Trojanowski JQ. Advancing Alzheimer's disease diagnosis, treatment, and care: recommendations from the Ware Invitational Summit. Alzheimers Dement. 2012 Sep;8(5):445-52. doi: 10.1016/j.jalz.2012.08.001.
- Background: PubMed 17716075Albert MS, Blacker D. Mild cognitive impairment and dementia. Annu Rev Clin Psychol. 2006;2:379-88. doi: 10.1146/annurev.clinpsy.1.102803.144039.
- Background: PubMed 18500688Mitchell AJ. The clinical significance of subjective memory complaints in the diagnosis of mild cognitive impairment and dementia: a meta-analysis. Int J Geriatr Psychiatry. 2008 Nov;23(11):1191-202. doi: 10.1002/gps.2053.
- Background: PubMed 16286908Matsuda T, Takayama T, Tashiro M, Nakamura Y, Ohashi Y, Shimozuma K. Mild cognitive impairment after adjuvant chemotherapy in breast cancer patients--evaluation of appropriate research design and methodology to measure symptoms. Breast Cancer. 2005;12(4):279-87. doi: 10.2325/jbcs.12.279.
- Background: PubMed 10190820Petersen RC, Smith GE, Waring SC, Ivnik RJ, Tangalos EG, Kokmen E. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999 Mar;56(3):303-8. doi: 10.1001/archneur.56.3.303.
- Background: PubMed 9330992Braak H, Braak E. Diagnostic criteria for neuropathologic assessment of Alzheimer's disease. Neurobiol Aging. 1997 Jul-Aug;18(4 Suppl):S85-8. doi: 10.1016/s0197-4580(97)00062-6.
- Background: PubMed 7504355Selkoe DJ. Physiological production of the beta-amyloid protein and the mechanism of Alzheimer's disease. Trends Neurosci. 1993 Oct;16(10):403-9. doi: 10.1016/0166-2236(93)90008-a.
- Background: PubMed 10735393Naslund J, Haroutunian V, Mohs R, Davis KL, Davies P, Greengard P, Buxbaum JD. Correlation between elevated levels of amyloid beta-peptide in the brain and cognitive decline. JAMA. 2000 Mar 22-29;283(12):1571-7. doi: 10.1001/jama.283.12.1571.
- Background: PubMed 11788052Arendash GW, Gordon MN, Diamond DM, Austin LA, Hatcher JM, Jantzen P, DiCarlo G, Wilcock D, Morgan D. Behavioral assessment of Alzheimer's transgenic mice following long-term Abeta vaccination: task specificity and correlations between Abeta deposition and spatial memory. DNA Cell Biol. 2001 Nov;20(11):737-44. doi: 10.1089/10445490152717604.
- Background: PubMed 21532539Mosconi L, McHugh PF. FDG- and amyloid-PET in Alzheimer's disease: is the whole greater than the sum of the parts? Q J Nucl Med Mol Imaging. 2011 Jun;55(3):250-64.
- Background: PubMed 19587325Okello A, Koivunen J, Edison P, Archer HA, Turkheimer FE, Nagren K, Bullock R, Walker Z, Kennedy A, Fox NC, Rossor MN, Rinne JO, Brooks DJ. Conversion of amyloid positive and negative MCI to AD over 3 years: an 11C-PIB PET study. Neurology. 2009 Sep 8;73(10):754-60. doi: 10.1212/WNL.0b013e3181b23564. Epub 2009 Jul 8.
- Background: PubMed 20147655Resnick SM, Sojkova J, Zhou Y, An Y, Ye W, Holt DP, Dannals RF, Mathis CA, Klunk WE, Ferrucci L, Kraut MA, Wong DF. Longitudinal cognitive decline is associated with fibrillar amyloid-beta measured by [11C]PiB. Neurology. 2010 Mar 9;74(10):807-15. doi: 10.1212/WNL.0b013e3181d3e3e9. Epub 2010 Feb 10.
- Individual participant dataSharing planned: Undecided
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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.
Norman L. Foster, M.D. principal investigator
Director: Center for Alzheimer's Care, Imaging & Research; Chief: Division of Cognitive Neurology; Senior Investigator: The Brain Institute; Professor: Dept. of Neurology University of Utah School of Medicine
John M. Hoffman, M.D. principal investigator
Professor of Radiology and Neurology Director of Nuclear Medicine; Director: Center for Quantitative Cancer Imaging Huntsman Cancer Institute University of Utah School of Medicine
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 Mild Cognitive Impairment and Dementia, run by University of Utah 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 12 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: finished, as of the sponsor's last update on 24 Apr 2023. 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 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?
Proportion of care practices changed after amyloid PET scan (time frame: Visit 1, 30 days prior to scan and Visit 4, 90 days after scan). 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 NCT02778971, 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 24 Apr 2023.