Alzheimer DiseasePCD=OOALZNCT02835716
Pre-Clinical (Alzheimers) Diagnosis PCD = Optimum Outcomes OO
An observational study of Alzheimer Disease, run by Millennium Magnetic Technologies, LLC at 1 site in United States.
Trial summary
This Observational protocol will attempt to verify two recent and very critical concepts in ALZ Clinical Research by studying high-risk individuals who already are taking medications which may prevent the onset of ALZ. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- roflumilast and ustekinumab
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2020
- How long will I take part?
- 5 Years
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults at high risk of developing ALZ within 18-48 months but are currently cognitively normal for their age sex matching group. Risk factors include parents with a history of ALZ, and/or positive APOE4 alleles.
Who may be able to join
- 50 to 75 years old,
- Normal baseline cognitive function by standard psychometric testing.
- Able to privately fund psychometric and neuroimaging studies if not covered by their insurance,
- Able to give written Informed Consent,
- Ascent for collaboration by their primary care or specialty physician,
- Currently taking (<1 month) or planning to take (within the next 3 months) medications which are identified in the study group of interest, prescribed by and under the care of a PMD or specialty physician.
Who cannot join
- Inability to undergo MR Imaging : Claustrophobia, certain metal implants,
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Millennium Magnetic Technologies, LLC
Westport, Connecticut, 06880
Steve Levy, MD, 203-423-9494, SL@MilMag.net
Donald H Marks, MD PhD, 9733070364, DHM@MilMag.net
About this study
Official title: Pre-Clinical Alzheimer's (ALZ) Diagnosis (PCD) = Optimum Outcomes (OO)
This Observational protocol will attempt to verify two recent and very critical concepts in ALZ Clinical Research by studying high-risk individuals who already are taking medications which may prevent the onset of ALZ.
- It may be possible to determine the future development of ALZ in a preclinical state in a cognitively normal but high risk individual at least 18-24 months before any symptoms develop of cognitive impairment.
- Early treatment of these cognitively normal high-risk persons with subclinical pre-ALZ can prevent of delay the occurrence and severity of ALZ.
Read more
Caveats
Neither this protocol nor the fMRI imaging are designed or intended to diagnose or treat ALZ, nor develop or use medications or diagnostic neuroimaging outside of already approved and accepted parameters. Persons who volunteer to be study subjects in this observational protocol will be under the care of their primary care / specialty physician, who will order tests and treatments as they see appropriate.
Although there is a very large body of peer-reviewed scientific literature demonstrating that certain functional MRI patterns are associated with certain neurologic conditions, the utilization of fMRI for the evaluation of neurologic disorders is still considered an emerging science and therefore in the investigational stage. Although this protocol will report on brain patterns of certain neurologic conditions such as cognitive impairment and Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are not considered stand alone or diagnostic per se and should always be considered by the PMD in conjunction with the patient's clinical condition. These data should only be used as additional information to add to the PMD's diagnostic impression.
Read the detailed description
Prospective observational study participants age 50-75 years are identified who are currently (<1 month) taking or will soon (within 3 months) start taking study medications of interest thru their own physician.
Prospective observational study participants are explained how persons can be cognitively normal but at high risk for developing clinical ALZ, and that this risk can be prospectively identified.
They are advised that there is some rationale that medications they are or will soon be taking may have a protective effect in delaying the onset of ALZ, and that protective effect can be monitored.
They are asked if they would like to participate in a protocol that monitors their prospective risk for developing ALZ short term, and whether certain of their prescribed medications may have a protective effect. Those who are accepting to be participants are then enrolled in the study.
Enrollees are tested for risk factors for having pre-clinical ALZ. Individuals identified as being at risk at baseline are followed at 6 month intervals for a 24 month period using psychometric testing and functional neuroimaging. Their maintenance of cognitive stability or cognitive decline is monitored while under the care of their PMD and while taking medications of interest.
- Conditions
- Alzheimer Disease
- Being tested
- roflumilast, ustekinumab
- Keywords
- Phosphodiesterase type 4 inhibitor, ustekinumab, secukinumab, P40 subunit, Interleukin IL-12, Interleukin IL-23, Apoprotein e4, Interleukin IL-17A
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
roflumilastDrug
Also called Daliresp
DALIRESP is used in adults with severe chronic obstructive pulmonary disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations
ustekinumabBiological
Also called Stelara
STELARA is approved to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Develop Cognitive Decline
Cognitive decline is defined as a reduction from baseline performance within each individual of at least one standard deviation (SD) on at least one of the three principal outcome indices (DRS-2, RAVLT Sum of Trials 1-5 [T1- 5], RAVLT Delayed Recall [DR]).
Measured: 18-24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Millennium Magnetic Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald H Marks, MD PhD, Principal investigator, MMT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835716
- Sponsor's protocol ID
- PCD=OO ALZ
- Acronym
- PCD=OOALZ
- Status last verified
- Sep 2016
- First submitted
- 10 Jul 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Bangen KJ, Restom K, Liu TT, Wierenga CE, Jak AJ, Salmon DP, Bondi MW. Assessment of Alzheimer's disease risk with functional magnetic resonance imaging: an arterial spin labeling study. J Alzheimers Dis. 2012;31 Suppl 3(0):S59-74. doi: 10.3233/JAD-2012-120292.
PubMed 22531427Caltagirone C, Ferrannini L, Marchionni N, Nappi G, Scapagnini G, Trabucchi M. The potential protective effect of tramiprosate (homotaurine) against Alzheimer's disease: a review. Aging Clin Exp Res. 2012 Dec;24(6):580-7. doi: 10.3275/8585. Epub 2012 Sep 5.
PubMed 22961121Cavedo E, Lista S, Khachaturian Z, Aisen P, Amouyel P, Herholz K, Jack CR Jr, Sperling R, Cummings J, Blennow K, O'Bryant S, Frisoni GB, Khachaturian A, Kivipelto M, Klunk W, Broich K, Andrieu S, de Schotten MT, Mangin JF, Lammertsma AA, Johnson K, Teipel S, Drzezga A, Bokde A, Colliot O, Bakardjian H, Zetterberg H, Dubois B, Vellas B, Schneider LS, Hampel H. The Road Ahead to Cure Alzheimer's Disease: Development of Biological Markers and Neuroimaging Methods for Prevention Trials Across all Stages and Target Populations. J Prev Alzheimers Dis. 2014 Dec;1(3):181-202. doi: 10.14283/jpad.2014.32.
PubMed 26478889Chincarini A, Bosco P, Calvini P, Gemme G, Esposito M, Olivieri C, Rei L, Squarcia S, Rodriguez G, Bellotti R, Cerello P, De Mitri I, Retico A, Nobili F; Alzheimer's Disease Neuroimaging Initiative. Local MRI analysis approach in the diagnosis of early and prodromal Alzheimer's disease. Neuroimage. 2011 Sep 15;58(2):469-80. doi: 10.1016/j.neuroimage.2011.05.083. Epub 2011 Jun 16.
PubMed 21718788Chiang K, Koo EH. Emerging therapeutics for Alzheimer's disease. Annu Rev Pharmacol Toxicol. 2014;54:381-405. doi: 10.1146/annurev-pharmtox-011613-135932.
PubMed 24392696Chao S, Roberts JS, Marteau TM, Silliman R, Cupples LA, Green RC. Health behavior changes after genetic risk assessment for Alzheimer disease: The REVEAL Study. Alzheimer Dis Assoc Disord. 2008 Jan-Mar;22(1):94-7. doi: 10.1097/WAD.0b013e31815a9dcc.
PubMed 18317253Deardorff WJ, Grossberg GT. Targeting neuroinflammation in Alzheimer's disease: evidence for NSAIDs and novel therapeutics. Expert Rev Neurother. 2017 Jan;17(1):17-32. doi: 10.1080/14737175.2016.1200972. Epub 2016 Jun 24.
PubMed 27293026Garcia-Osta A, Cuadrado-Tejedor M, Garcia-Barroso C, Oyarzabal J, Franco R. Phosphodiesterases as therapeutic targets for Alzheimer's disease. ACS Chem Neurosci. 2012 Nov 21;3(11):832-44. doi: 10.1021/cn3000907. Epub 2012 Oct 1.
PubMed 23173065Galluzzi S, Marizzoni M, Babiloni C, Albani D, Antelmi L, Bagnoli C, Bartres-Faz D, Cordone S, Didic M, Farotti L, Fiedler U, Forloni G, Girtler N, Hensch T, Jovicich J, Leeuwis A, Marra C, Molinuevo JL, Nobili F, Pariente J, Parnetti L, Payoux P, Del Percio C, Ranjeva JP, Rolandi E, Rossini PM, Schonknecht P, Soricelli A, Tsolaki M, Visser PJ, Wiltfang J, Richardson JC, Bordet R, Blin O, Frisoni GB; PharmaCog Consortium. Clinical and biomarker profiling of prodromal Alzheimer's disease in workpackage 5 of the Innovative Medicines Initiative PharmaCog project: a 'European ADNI study'. J Intern Med. 2016 Jun;279(6):576-91. doi: 10.1111/joim.12482. Epub 2016 Mar 4.
PubMed 26940242Griffin WS. Neuroinflammatory cytokine signaling and Alzheimer's disease. N Engl J Med. 2013 Feb 21;368(8):770-1. doi: 10.1056/NEJMcibr1214546. No abstract available.
PubMed 23425171Gurney ME, D'Amato EC, Burgin AB. Phosphodiesterase-4 (PDE4) molecular pharmacology and Alzheimer's disease. Neurotherapeutics. 2015 Jan;12(1):49-56. doi: 10.1007/s13311-014-0309-7.
PubMed 25371167Christensen KD, Roberts JS, Whitehouse PJ, Royal CD, Obisesan TO, Cupples LA, Vernarelli JA, Bhatt DL, Linnenbringer E, Butson MB, Fasaye GA, Uhlmann WR, Hiraki S, Wang N, Cook-Deegan R, Green RC; REVEAL Study Group*. Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2016 Feb 2;164(3):155-63. doi: 10.7326/M15-0187. Epub 2016 Jan 26.
PubMed 26810768Green RC, Christensen KD, Cupples LA, Relkin NR, Whitehouse PJ, Royal CD, Obisesan TO, Cook-Deegan R, Linnenbringer E, Butson MB, Fasaye GA, Levinson E, Roberts JS; REVEAL Study Group. A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease. Alzheimers Dement. 2015 Oct;11(10):1222-30. doi: 10.1016/j.jalz.2014.10.014. Epub 2014 Dec 9.
PubMed 25499536Haller S, Nguyen D, Rodriguez C, Emch J, Gold G, Bartsch A, Lovblad KO, Giannakopoulos P. Individual prediction of cognitive decline in mild cognitive impairment using support vector machine-based analysis of diffusion tensor imaging data. J Alzheimers Dis. 2010;22(1):315-27. doi: 10.3233/JAD-2010-100840.
PubMed 20847435Heckman PR, Wouters C, Prickaerts J. Phosphodiesterase inhibitors as a target for cognition enhancement in aging and Alzheimer's disease: a translational overview. Curr Pharm Des. 2015;21(3):317-31. doi: 10.2174/1381612820666140826114601.
PubMed 25159073
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Clinical Alzheimer's (ALZ) Diagnosis (PCD) = Optimum Outcomes (OO)
- ClinicalTrials.gov ID
- NCT02835716
- Acronym / sponsor ID
- PCD=OOALZ / PCD=OO ALZ
- Conditions
- Alzheimer Disease
- Keywords
- Phosphodiesterase type 4 inhibitor, ustekinumab, secukinumab, P40 subunit, Interleukin IL-12, Interleukin IL-23, Apoprotein e4, Interleukin IL-17A
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Millennium Magnetic Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 18 Jul 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.
This Observational protocol will attempt to verify two recent and very critical concepts in ALZ Clinical Research by studying high-risk individuals who already are taking medications which may prevent the onset of ALZ.
- It may be possible to determine the future development of ALZ in a preclinical state in a cognitively normal but high risk individual at least 18-24 months before any symptoms develop of cognitive impairment.
- Early treatment of these cognitively normal high-risk persons with subclinical pre-ALZ can prevent of delay the occurrence and severity of ALZ.
Caveats
Neither this protocol nor the fMRI imaging are designed or intended to diagnose or treat ALZ, nor develop or use medications or diagnostic neuroimaging outside of already approved and accepted parameters. Persons who volunteer to be study subjects in this observational protocol will be under the care of their primary care / specialty physician, who will order tests and treatments as they see appropriate.
Although there is a very large body of peer-reviewed scientific literature demonstrating that certain functional MRI patterns are associated with certain neurologic conditions, the utilization of fMRI for the evaluation of neurologic disorders is still considered an emerging science and therefore in the investigational stage. Although this protocol will report on brain patterns of certain neurologic conditions such as cognitive impairment and Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are not considered stand alone or diagnostic per se and should always be considered by the PMD in conjunction with the patient's clinical condition. These data should only be used as additional information to add to the PMD's diagnostic impression.
Detailed description
Prospective observational study participants age 50-75 years are identified who are currently (<1 month) taking or will soon (within 3 months) start taking study medications of interest thru their own physician.
Prospective observational study participants are explained how persons can be cognitively normal but at high risk for developing clinical ALZ, and that this risk can be prospectively identified.
They are advised that there is some rationale that medications they are or will soon be taking may have a protective effect in delaying the onset of ALZ, and that protective effect can be monitored.
They are asked if they would like to participate in a protocol that monitors their prospective risk for developing ALZ short term, and whether certain of their prescribed medications may have a protective effect. Those who are accepting to be participants are then enrolled in the study.
Enrollees are tested for risk factors for having pre-clinical ALZ. Individuals identified as being at risk at baseline are followed at 6 month intervals for a 24 month period using psychometric testing and functional neuroimaging. Their maintenance of cognitive stability or cognitive decline is monitored while under the care of their PMD and while taking medications of interest.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults at high risk of developing ALZ within 18-48 months but are currently cognitively normal for their age sex matching group. Risk factors include parents with a history of ALZ, and/or positive APOE4 alleles.
Key inclusion criteria (6 listed)
- 50 to 75 years old,
- Normal baseline cognitive function by standard psychometric testing.
- Able to privately fund psychometric and neuroimaging studies if not covered by their insurance,
- Able to give written Informed Consent,
- Ascent for collaboration by their primary care or specialty physician,
Key exclusion criteria (1 listed)
- Inability to undergo MR Imaging : Claustrophobia, certain metal implants,
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 |
|---|---|---|
| roflumilastAlso: DalirespDALIRESP is used in adults with severe chronic obstructive pulmonary disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations | Drug | – |
| ustekinumabAlso: StelaraSTELARA is approved to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body | Biological | – |
Primary outcome
Number of Participants who Develop Cognitive Decline
Time frame: 18-24 month
Cognitive decline is defined as a reduction from baseline performance within each individual of at least one standard deviation (SD) on at least one of the three principal outcome indices (DRS-2, RAVLT Sum of Trials 1-5 [T1- 5], RAVLT Delayed Recall [DR]).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 22531427Bangen KJ, Restom K, Liu TT, Wierenga CE, Jak AJ, Salmon DP, Bondi MW. Assessment of Alzheimer's disease risk with functional magnetic resonance imaging: an arterial spin labeling study. J Alzheimers Dis. 2012;31 Suppl 3(0):S59-74. doi: 10.3233/JAD-2012-120292.
- Background: PubMed 22961121Caltagirone C, Ferrannini L, Marchionni N, Nappi G, Scapagnini G, Trabucchi M. The potential protective effect of tramiprosate (homotaurine) against Alzheimer's disease: a review. Aging Clin Exp Res. 2012 Dec;24(6):580-7. doi: 10.3275/8585. Epub 2012 Sep 5.
- Background: PubMed 26478889Cavedo E, Lista S, Khachaturian Z, Aisen P, Amouyel P, Herholz K, Jack CR Jr, Sperling R, Cummings J, Blennow K, O'Bryant S, Frisoni GB, Khachaturian A, Kivipelto M, Klunk W, Broich K, Andrieu S, de Schotten MT, Mangin JF, Lammertsma AA, Johnson K, Teipel S, Drzezga A, Bokde A, Colliot O, Bakardjian H, Zetterberg H, Dubois B, Vellas B, Schneider LS, Hampel H. The Road Ahead to Cure Alzheimer's Disease: Development of Biological Markers and Neuroimaging Methods for Prevention Trials Across all Stages and Target Populations. J Prev Alzheimers Dis. 2014 Dec;1(3):181-202. doi: 10.14283/jpad.2014.32.
- Background: PubMed 21718788Chincarini A, Bosco P, Calvini P, Gemme G, Esposito M, Olivieri C, Rei L, Squarcia S, Rodriguez G, Bellotti R, Cerello P, De Mitri I, Retico A, Nobili F; Alzheimer's Disease Neuroimaging Initiative. Local MRI analysis approach in the diagnosis of early and prodromal Alzheimer's disease. Neuroimage. 2011 Sep 15;58(2):469-80. doi: 10.1016/j.neuroimage.2011.05.083. Epub 2011 Jun 16.
- Background: PubMed 24392696Chiang K, Koo EH. Emerging therapeutics for Alzheimer's disease. Annu Rev Pharmacol Toxicol. 2014;54:381-405. doi: 10.1146/annurev-pharmtox-011613-135932.
- Background: PubMed 18317253Chao S, Roberts JS, Marteau TM, Silliman R, Cupples LA, Green RC. Health behavior changes after genetic risk assessment for Alzheimer disease: The REVEAL Study. Alzheimer Dis Assoc Disord. 2008 Jan-Mar;22(1):94-7. doi: 10.1097/WAD.0b013e31815a9dcc.
- Background: PubMed 27293026Deardorff WJ, Grossberg GT. Targeting neuroinflammation in Alzheimer's disease: evidence for NSAIDs and novel therapeutics. Expert Rev Neurother. 2017 Jan;17(1):17-32. doi: 10.1080/14737175.2016.1200972. Epub 2016 Jun 24.
- Background: PubMed 23173065Garcia-Osta A, Cuadrado-Tejedor M, Garcia-Barroso C, Oyarzabal J, Franco R. Phosphodiesterases as therapeutic targets for Alzheimer's disease. ACS Chem Neurosci. 2012 Nov 21;3(11):832-44. doi: 10.1021/cn3000907. Epub 2012 Oct 1.
- Background: PubMed 26940242Galluzzi S, Marizzoni M, Babiloni C, Albani D, Antelmi L, Bagnoli C, Bartres-Faz D, Cordone S, Didic M, Farotti L, Fiedler U, Forloni G, Girtler N, Hensch T, Jovicich J, Leeuwis A, Marra C, Molinuevo JL, Nobili F, Pariente J, Parnetti L, Payoux P, Del Percio C, Ranjeva JP, Rolandi E, Rossini PM, Schonknecht P, Soricelli A, Tsolaki M, Visser PJ, Wiltfang J, Richardson JC, Bordet R, Blin O, Frisoni GB; PharmaCog Consortium. Clinical and biomarker profiling of prodromal Alzheimer's disease in workpackage 5 of the Innovative Medicines Initiative PharmaCog project: a 'European ADNI study'. J Intern Med. 2016 Jun;279(6):576-91. doi: 10.1111/joim.12482. Epub 2016 Mar 4.
- Background: PubMed 23425171Griffin WS. Neuroinflammatory cytokine signaling and Alzheimer's disease. N Engl J Med. 2013 Feb 21;368(8):770-1. doi: 10.1056/NEJMcibr1214546. No abstract available.
- Background: PubMed 25371167Gurney ME, D'Amato EC, Burgin AB. Phosphodiesterase-4 (PDE4) molecular pharmacology and Alzheimer's disease. Neurotherapeutics. 2015 Jan;12(1):49-56. doi: 10.1007/s13311-014-0309-7.
- Background: PubMed 26810768Christensen KD, Roberts JS, Whitehouse PJ, Royal CD, Obisesan TO, Cupples LA, Vernarelli JA, Bhatt DL, Linnenbringer E, Butson MB, Fasaye GA, Uhlmann WR, Hiraki S, Wang N, Cook-Deegan R, Green RC; REVEAL Study Group*. Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2016 Feb 2;164(3):155-63. doi: 10.7326/M15-0187. Epub 2016 Jan 26.
- Multidimensional Representation of Concepts as Cognitive Engrams in the Human BrainLink provided by the sponsor.
- Evaluation of Cognitive ImpairmentLink provided by the sponsor.
- Ustekinumab New Drug Therapy for Cognitive Decline resulting from Neuroinflammatory Cytokine Signaling and Alzheimer's DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Donald H Marks, MD PhD principal investigator
MMT
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 Alzheimer Disease, run by Millennium Magnetic Technologies, LLC 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 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald H Marks, MD PhD (9733070364, DHM@MilMag.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Develop Cognitive Decline (time frame: 18-24 month). 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 NCT02835716, which also lists 26 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 13 Sep 2016.