Neuroinflammation and Cognitive Decline in Alzheimer Disease

Alzheimer Disease Clinical Trial

— NICAD  

Official title:

Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377206
• Other study ID #: PRTS13-CH / NICAD
• Status: Completed
• Phase: Early Phase 1
• Start date: April 6, 2016
• Est. completion date: December 4, 2019

Study information

• Verified date: September 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Other:
• ADAS-Cog evaluation
[18F]DPA-714 PET imaging

Locations

Country	Name	City	State
France	university hospital of Nantes	Nantes
France	University Hospital of Rennes	Rennes
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (4)

Helmer C, Andrieu S, Pérès 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. Epub 2007 Jan 11. — View Citation

Lo RY, Jagust WJ; Alzheimer's Disease Neuroimaging Initiative. Vascular burden and Alzheimer disease pathologic progression. Neurology. 2012 Sep 25;79(13):1349-55. Epub 2012 Sep 12. — View Citation

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. Review. — View Citation

Soto 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		inclusion and 24 months
Secondary	Relationship passessment between [18F]DPA-714 fixing		Inclusion and 34 months