Alzheimer DiseaseEarly Phase 1NICADNCT02377206
Neuroinflammation and Cognitive Decline in Alzheimer Disease
A Early Phase 1 study testing ADAS-Cog evaluation in people with Alzheimer Disease, run by University Hospital, Tours at 3 sites in France.
Trial summary
The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- ADAS-Cog evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Apr 2016to 4 Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age more than 50 years (included)
- necessary knowledge of French (write and oral) to do neuropsychological tests
- Study level upper (or equal) than 7 years (considering first year of grammar-school as start)
- People with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards : Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)
- Social security affiliation.
Who cannot join
- MMSE score lower than 15 and upper or equal to 26
- Evolutive disease which could possibly had consequences on central nervous system
- Inflammatory disease or evolutive neoplasia and/or C reactive protein (CRP) upper than 10mg/L
- Chronic use of alchohol and/or drug
- Serious depression defined by Montgomery Asberg Depression Rating Scale (MADRS) score higher than 18
- Surgical or medical condition in the last 3 months
Show all 15Show fewer
- Long term treatment which could possibly interfere with inflammatory process (especially the month before PET [18F]DPA-714 imaging).
- Treatment by N-Methyl-D-Aspartate antagonist
- Treatment by Minocycline
- Treatment by benzodiazepine (especially the month before PET [18F]DPA-714 imaging) (Zolpidem, zopiclone and loprazolam excepted)
- Anomaly at neurological examination which is not a classical symptom
- Contraindication to magnetic resonance imaging (RMI)
- Florbetapir[18F] hypersensibility
- Participation to an other experimental protocol with drug.
- people under guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites
university hospital of Nantes
Nantes, 44000
University Hospital of Rennes
Rennes, 35000
University Hospital of Tours
Tours, 37044
About this study
Official title: Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714
The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).
Read the detailed description
The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714 , and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by ADAS-Cog and MMSE scores).
(DPA-714 : N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide)
- Conditions
- Alzheimer Disease
- Being tested
- ADAS-Cog evaluation
- Keywords
- PET, [18F]DPA-714, cognitive decline
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAS-Cog evaluationOther
[18F]DPA-714 PET imaging
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Disease | Experimental | Alzheimer Disease People ADAS-Cog evaluation PET imaging with [18F]DPA-714 Receives: Other: ADAS-Cog evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint
Measured: inclusion and 24 months
Secondary outcomes (1)
Relationship passessment between [18F]DPA-714 fixing
Measured: Inclusion and 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study start6 Apr 2016
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent CAMUS, PhD, Principal investigator, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377206
- Sponsor's protocol ID
- PRTS13-CH / NICAD
- Acronym
- NICAD
- Status last verified
- Sep 2022
- First submitted
- 17 Feb 2015
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt C, Wolff M, Weitz M, Bartlau T, Korth C, Zerr I. Rapidly progressive Alzheimer disease. Arch Neurol. 2011 Sep;68(9):1124-30. doi: 10.1001/archneurol.2011.189.
PubMed 21911694Soto ME, Andrieu S, Arbus C, Ceccaldi M, Couratier P, Dantoine T, Dartigues JF, Gillette-Guyonnet S, Nourhashemi F, Ousset PJ, Poncet M, Portet F, Touchon J, Vellas B. Rapid cognitive decline in Alzheimer's disease. Consensus paper. J Nutr Health Aging. 2008 Dec;12(10):703-13. doi: 10.1007/BF03028618.
PubMed 19043645Helmer C, Andrieu S, Peres K, Orgogozo JM, Vellas B, Dartigues JF; REAL.fr Group. Predictive value of 6-month decline in ADAS-cog for survival without severe Alzheimer's disease. Dement Geriatr Cogn Disord. 2007;23(3):168-74. doi: 10.1159/000098516. Epub 2007 Jan 11.
PubMed 17215578Lo RY, Jagust WJ; Alzheimer's Disease Neuroimaging Initiative. Vascular burden and Alzheimer disease pathologic progression. Neurology. 2012 Sep 25;79(13):1349-55. doi: 10.1212/WNL.0b013e31826c1b9d. Epub 2012 Sep 12.
PubMed 22972646
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714
- ClinicalTrials.gov ID
- NCT02377206
- Acronym / sponsor ID
- NICAD / PRTS13-CH / NICAD
- Conditions
- Alzheimer Disease
- Keywords
- PET, [18F]DPA-714, cognitive decline
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 3 Mar 2015 (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 purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).
Detailed description
The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714 , and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by ADAS-Cog and MMSE scores).
(DPA-714 : N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Disease | Experimental | Other: ADAS-Cog evaluationAlzheimer Disease People ADAS-Cog evaluation PET imaging with [18F]DPA-714 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent
- Age more than 50 years (included)
- necessary knowledge of French (write and oral) to do neuropsychological tests
- Study level upper (or equal) than 7 years (considering first year of grammar-school as start)
- People with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards : Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)
Key exclusion criteria (15 listed)
- MMSE score lower than 15 and upper or equal to 26
- Evolutive disease which could possibly had consequences on central nervous system
- Inflammatory disease or evolutive neoplasia and/or C reactive protein (CRP) upper than 10mg/L
- Chronic use of alchohol and/or drug
- Serious depression defined by Montgomery Asberg Depression Rating Scale (MADRS) score higher than 18
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 |
|---|---|---|
| ADAS-Cog evaluation[18F]DPA-714 PET imaging | Other | Alzheimer Disease |
Primary outcome
Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint
Time frame: inclusion and 24 months
1 secondary outcome
Relationship passessment between [18F]DPA-714 fixing
Time frame: Inclusion and 34 months
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 14 Sep 2022.
- Background: PubMed 21911694Schmidt C, Wolff M, Weitz M, Bartlau T, Korth C, Zerr I. Rapidly progressive Alzheimer disease. Arch Neurol. 2011 Sep;68(9):1124-30. doi: 10.1001/archneurol.2011.189.
- Background: PubMed 19043645Soto ME, Andrieu S, Arbus C, Ceccaldi M, Couratier P, Dantoine T, Dartigues JF, Gillette-Guyonnet S, Nourhashemi F, Ousset PJ, Poncet M, Portet F, Touchon J, Vellas B. Rapid cognitive decline in Alzheimer's disease. Consensus paper. J Nutr Health Aging. 2008 Dec;12(10):703-13. doi: 10.1007/BF03028618.
- Background: PubMed 17215578Helmer C, Andrieu S, Peres K, Orgogozo JM, Vellas B, Dartigues JF; REAL.fr Group. Predictive value of 6-month decline in ADAS-cog for survival without severe Alzheimer's disease. Dement Geriatr Cogn Disord. 2007;23(3):168-74. doi: 10.1159/000098516. Epub 2007 Jan 11.
- Background: PubMed 22972646Lo RY, Jagust WJ; Alzheimer's Disease Neuroimaging Initiative. Vascular burden and Alzheimer disease pathologic progression. Neurology. 2012 Sep 25;79(13):1349-55. doi: 10.1212/WNL.0b013e31826c1b9d. Epub 2012 Sep 12.
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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.
Vincent CAMUS, PhD principal investigator
University Hospital of Tours
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ADAS-Cog evaluation in people with Alzheimer Disease, run by University Hospital, Tours at 3 sites in France.
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 15 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint (time frame: inclusion and 24 months). 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 NCT02377206, which also lists 4 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 14 Sep 2022.