Neuroinflammation and Cognitive Decline in Alzheimer Disease

NCT02377206 | Completed Early Phase 1

• 1 other identifier: PRTS13-CH / NICAD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Alzheimer Disease

Keywords

PET; [18F]DPA-714; cognitive decline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relationship passessment between [18F]DPA-714 fixing

  Inclusion and 34 months

Study Arms (1)

Alzheimer Disease

EXPERIMENTAL

Alzheimer Disease People ADAS-Cog evaluation PET imaging with \[18F\]DPA-714

Other: ADAS-Cog evaluation

Interventions

ADAS-Cog evaluation OTHER

\[18F\]DPA-714 PET imaging

Alzheimer Disease

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

university hospital of Nantes

Nantes, 44000, France

Location

University Hospital of Rennes

Rennes, 35000, France

Location

University Hospital of Tours

Tours, 37044, France

Location

Related Publications (4)

• 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.

  PMID: 21911694 BACKGROUND

• 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. doi: 10.1007/BF03028618.

  PMID: 19043645 BACKGROUND

• Helmer 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.

  PMID: 17215578 BACKGROUND

• Lo 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.

  PMID: 22972646 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Vincent CAMUS, PhD

  University Hospital of Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 3, 2015
• Study Start: April 6, 2016
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

FR (3)