Mild Cognitive ImpairmentIMPACT2NCT02781220
Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
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 build upon the evidence captured in the Imaging Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information regarding patient-reported outcomes and physician confidence in diagnosis and management based on the Implications for Management of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Alzheimer's Disease
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 10 Jun 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Participants must be Medicare beneficiaries referred by qualified dementia specialists and must meet AUC for amyloid PET (Johnson et al. 2013).
Who may be able to join
- 65 and older;
- Medicare beneficiary;
- Diagnosis of mild cognitive impairment (MCI) or dementia, according to Diagnostic and Statistical Manual - IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Meets 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;
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- Alzheimer's disease is a diagnostic consideration;
- Knowledge of amyloid PET status is expected to alter diagnosis and management.
- Head MRI and/or CT within 24 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;
- Able to tolerate amyloid PET required by protocol, to be performed at a participating PET facility;
- English or Spanish speaking (for the purposes of informed consent);
- Willing and able to provide consent. Consent may be by proxy.
Who cannot join
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- 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).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
- Hip/pelvic fracture within the 12 months prior to enrollment;
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- Body weight exceeds PET scanner weight limit;
- Life expectancy less than 24 months based on medical co-morbidities;
- Residence in a skilled nursing facility.
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 build upon the evidence captured in the Imaging Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information regarding patient-reported outcomes and physician confidence in diagnosis and management based on the Implications for Management of PET Amyloid Classification Technology (IMPACT; NCT number not yet assigned) trial design.
Read the detailed description
The primary purpose of this prospective, observational study is to examine the benefit of amyloid positron emission tomography and computed tomography (PET/CT) scan in clinical practice for participants at our site that are enrolled in the IDEAS (NCT02420756) trial. To accomplish this, when a clinician has ordered an amyloid 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.
Objectives
AIM 1: to assess the change in diagnosis and management, related to 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 confidence increase through use of vendor supplied semi-quantitative software
AIM 4: to assess adherence to identified patient management related to care practices and drug management
- Conditions
- Mild Cognitive Impairment, Dementia, Alzheimer's Disease
- Keywords
- MCI, Dementia, amyloid PET, physician diagnosis, Alzheimer's disease, AD, PET imaging, Appropriate Use Criteria, patient-reported outcomes, patient adherence
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Qualifying participants | All consented IDEAS trial participants will have additional data collected: visual and semi-quantitative software aided amyloid PET scan interpretation, care partner questionnaires and documented provider diagnosis, diagnostic confidence, and management plan following the IMPACT design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change in care practices 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 (14)
Percentage of change in drug management options 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
Percentage 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 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 5-point scale of care partner confidence in diagnosis before and after amyloid PET scan
Measured: Visit 1, 30 days prior to scan, Visit 4, 90 days after scan, Visit 5, 180 days after scan and Visit 6, 270 days after scan
Change in care partner satisfaction with evaluation after amyloid PET
Difference in 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 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: Visit 1, Visit 2, Visit 3, and Visit 4 90 days post scan
Percentage of change 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
Care partner's sustained confidence in diagnosis received after amyloid PET scan
Care partner confidence in diagnosis received after amyloid PET scan on a 5-point scale
Measured: Visit 4, Visit 5, and Visit 6, 270 days post scan
Care partner's sustained confidence in ability to adhere to management plan received after amyloid PET scan
Care partner confidence in ability to follow management plan outlined by physician after amyloid PET scan on a 5-point scale
Measured: Visit 4, Visit 5, and Visit 6, 270 days post scan
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, Visit 5, and Visit 6, 270 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, Visit 5, and Visit 6, 270 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 posted24 May 2016 (estimated)
- Study startJul 2016
- Primary completion10 Jun 2023
- Study completion10 Jun 2023
Why it stopped: IRB Study Closure - No HRPP Progress Update
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.
- More trials run by University of UtahThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 69 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 Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781220
- Sponsor's protocol ID
- 90351
- Acronym
- IMPACT2
- Status last verified
- Dec 2024
- First submitted
- 18 May 2016
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: only de-identified data will be shared
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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications for Management of PET Amyloid Classification Technology in the Imaging Dementia(IDEAS) Trial
- ClinicalTrials.gov ID
- NCT02781220
- Acronym / sponsor ID
- IMPACT2 / 90351
- 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
- TerminatedReason stopped: IRB Study Closure - No HRPP Progress Update
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 24 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 build upon the evidence captured in the Imaging Dementia - Evidence for Amyloid Scanning (IDEAS; NCT02420756) trial to include valuable information regarding patient-reported outcomes and physician confidence in diagnosis and management based on the Implications for Management of PET Amyloid Classification Technology (IMPACT; NCT number not yet assigned) trial design.
Detailed description
The primary purpose of this prospective, observational study is to examine the benefit of amyloid positron emission tomography and computed tomography (PET/CT) scan in clinical practice for participants at our site that are enrolled in the IDEAS (NCT02420756) trial. To accomplish this, when a clinician has ordered an amyloid 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.
Objectives
AIM 1: to assess the change in diagnosis and management, related to 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 confidence increase through use of vendor supplied semi-quantitative software
AIM 4: to assess adherence to identified patient management related to care practices and drug management
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualifying participants | – | –All consented IDEAS trial participants will have additional data collected: visual and semi-quantitative software aided amyloid PET scan interpretation, care partner questionnaires and documented provider diagnosis, diagnostic confidence, and management plan following the IMPACT design |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants must be Medicare beneficiaries referred by qualified dementia specialists and must meet AUC for amyloid PET (Johnson et al. 2013).
Key inclusion criteria (13 listed)
- 65 and older;
- Medicare beneficiary;
- Diagnosis of mild cognitive impairment (MCI) or dementia, according to Diagnostic and Statistical Manual - IV (DSM-IV) and/or National Institutes of Aging-Alzheimer's Association criteria, verified by a dementia specialist within 24 months (American Psychiatric Association. 2000; McKhann et al. 2011; Albert et al. 2011);
- Meets AUC:
- Cognitive complaint verified by objectively confirmed cognitive impairment;
Key exclusion criteria (9 listed)
- Normal cognition or subjective complaints that are not verified by cognitive testing.
- Knowledge of amyloid status, in the opinion of the referring dementia expert, may cause significant psychological harm or otherwise negatively impact the patient or family.
- 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).
- Cancer requiring active therapy (excluding non-melanoma skin cancer);
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
Percentage of change in care practices 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
14 secondary outcomes
Percentage of change in drug management options 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
Percentage 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, Visit 4, 90 days after scan, Visit 5, 180 days after scan and Visit 6, 270 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: Visit 1, Visit 2, Visit 3, and Visit 4 90 days post scan
Percentage of change exhibiting increased behavior disturbance when the diagnosis is given
Time frame: Visit 1, Visit 3, 60 days
Care partner's sustained confidence in diagnosis received after amyloid PET scan
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Care partner's sustained confidence in ability to adhere to management plan received after amyloid PET scan
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Percentage of recommended care practices adhered to after amyloid PET scan
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Percentage of recommended drug management adhered to after amyloid PET scan
Time frame: Visit 4, Visit 5, and Visit 6, 270 days post scan
Results and safety
The study was stopped early (reason given: IRB Study Closure - No HRPP Progress Update). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- 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. only de-identified data will be shared
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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
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 13 inclusion and 9 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 9 Dec 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.
Are results available for this study?
The study was stopped early (reason given: IRB Study Closure - No HRPP Progress Update). 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?
Percentage of change in care practices 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 NCT02781220, 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 9 Dec 2024.