Cholinergic Markers Alzheimer's Disease

NCT03090854 | Completed

• 2 other identifiers: K1604022016-AO1639-42
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Several previous studies have assessed acetylcholine (Ach) and acetylcholinesterase activity (AchE-a) levels in Alzheimer's disease (AD) pathophysiology. The cerebrospinal fluid (CSF) Ach level was significantly decreased in AD patients, and correlated positively with dementia score and MMSE (1, 2). Two studies have demonstrated positive correlations between CSF AchE-a and CSF Tau, phosphorylated-Tau (P-Tau) and AB 1-42 peptide (3,4). ChEIs (cholinesterase inhibitors) have been approved for the treatment of AD but only 20 to 30 % of patients are responders (5). Any consistent data allow the clinician to predict the response to the treatment. The link between basal cholinergic status and ChEIs efficiency has never been done. Even if, there is a wild research in AD treatment, ChEIs or treatment acting on the Ach pathways will remain a long time valuable treatment particularly in moderate AD in which disease modifying therapies did not show any efficiency. The investigators's objective is to prospectively explore the predicting value of CSF Ach and AchE-a levels on ChEIs response in AD patients.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; Cognition; Cholinergic target

Outcome Measures

Primary Outcomes (1)

• Neuropsychological test (ADASCog)

  "Responder" patients are defined by an improvement of at least 4 points on the ADAS-Cog (cognitive part) ADAS-Cog after 6 months of treatment. "Non-responders" are defined as aggravation, lack of improvement or improvement \<4 points on the ADAS-Cog scale

  between baseline and month 6

Secondary Outcomes (3)

• Rate of responder AD in this cohort included according to the new AD criteria and comparison of the current rate with the previous rate published using former AD criteria

  month 6

• Difference of CSF Ach AND AChE activity between responder and non responder groups

  month 6

• Statistical evaluation of the link between CSF Ach, AChE activity, total and phosphorylated Tau, Aß40 and Aß42.

  month 6

Study Arms (1)

Alzheimer disease patients

Diagnostic Test: ADASCog

Interventions

ADASCog DIAGNOSTIC_TEST

Neuropsychological test

Alzheimer disease patients

Eligibility Criteria

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

Study Population

Mild to moderate Alzheimer disease 's patients

You may qualify if:

• Male or Female aged ≥ 50 years
• Patients with a biological profile of CSF biomarkers in favor of Alzheimer's disease
• Alzheimer's disease diagnosed according to McKahnn 2011 criteria \[1\] at mild to moderate stage Clinical Dementia Rating (CDR) ≤2
• Indication to treatment with inhibitor of acetycholinesterase
• Patients benefiting from national health coverage
• Patients not subject to legal protection
• Fluent in French language

You may not qualify if:

• No indication or contraindication to PL
• Contraindications to IChEs
• Patient included in other anti-Alzheimer drug clinical trial
• Clinical Dementia Rating CDR\> 2
• Another cause of neurocognitive decline
• Serious psychiatric disorders
• Other serious life-threatening conditions

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre Mémoire de Ressources et de Recherche Paris Nord

Paris, 75010, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 27, 2017
• Study Start: November 8, 2017
• Primary Completion: January 12, 2021
• Study Completion: January 12, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

FR (1)