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BMJ Open. 2019 Jun 24;9(6):e029663. doi: 10.1136/bmjopen-2019-029663.

How many patients are eligible for disease-modifying treatment in Alzheimer's disease? A French national observational study over 5 years.

Author information

1
Institute of Memoryand Alzheimer's Disease (IM2A) and Brain and Spine Institute(ICM) UMR S 1127, Inria, Aramis-Project Team, Department of Neurology, AP-HP, Pitié-Salpêtrière University Hospital, Sorbonne Universities, Pierre et Marie Curie University, Paris 06 and National Reference Center for Rare or Early Dementias and Center of Excellence of Neurodegenerative Disease (CoEN), Paris, France.
2
Neurology Memory Center, Lariboisière FW Saint Louis University Hospital, Paris, France.
3
Center of Cognitive Neurology, Groupe hospitalier Lariboisiere Fernand-Widal, Paris, France.
4
Cognitive Neurology Center, CMRR Paris-Nord Ile-de-France, Groupe hospitalier Lariboisiere Fernand-Widal, Paris, France.
5
U942 Team Biomarkers and Neurocognition, INSERM/Université Paris Diderot, Paris, France.
6
Department of Neurology, Rouen University Hospital, Rouen, France.
7
Department of Neurology, CHU Charles Nicolle, Rouen, France.
8
Gériatrie, CHRU de Nancy, Nancy, France.
9
Gériatrie, CHU de Tours, Tours, France.
10
Department of Neurology, University Hospital of Strasbourg, Strasbourg, France.
11
Gériatrie, CHU de Strasbourg, Strasbourg, France.
12
Gériatrie, CHU de Poitiers, Poitiers, France.
13
Geriatrics Department University Hospital La Milétrie, Poitiers, France.
14
Neurology, Centre Hospitalier Regional et Universitaire de Lille (CHRU- LILLE), Lille, France.
15
Neurology, Centre Hospitalier Regional Universitaire de Lille Pole Neurosciences et Appareil Locomoteur, Lille, France.
16
CHU Nantes, Nantes, France.
17
Neurology, CHU de Nantes, Nantes, France.
18
Neurology, CHU de Dijon, Dijon, France.
19
Department of Neuropsychiatry, CHU de nice, Nice, France.
20
Centre Mémoire de Ressources et de Recherche, Centre Hospitalier Universitaire de Nice, Nice, France.
21
Department of Clinical Research, Institut du cerveau et de la moelle epiniere, Paris, France.
22
Délégation à la Recherche Clinique et à l'Innovation, Assistance publique-Hôpitaux de Paris, Paris, France.
23
Medical Department, Eli Lilly and Co, Indianapolis, Indiana, USA.
24
Neurology, CHU de la Pitiè Salpêtrière-AP-HP, Paris, France.

Abstract

OBJECTIVE:

We aimed to study the epidemiology of the prodromal and mild stages of Alzheimer's disease (AD) patients who are eligible for clinical trials with disease-modifying therapies.

SETTINGS:

We analysed two large complementary databases to study the incidence and characteristics of this population on a nationwide scope in France from 2014 to 2018. The National Alzheimer Database contains data from 357 memory centres and 90 private neurologists. Data from 2014 to 2018 have been analysed.

PARTICIPANTS:

Patients, 50-85 years old, diagnosed with AD who had an Mini-Mental State Exam (MMSE) score of ≥20 were included. We excluded patients with mixed and non-AD neurocognitive disorders.

PRIMARY OUTCOME MEASURE:

Descriptive statistics of the population of interest was the primary measure.

RESULTS:

In the National Alzheimer Database, 550 198 patients were assessed. Among them, 72 174 (13.1%) were diagnosed with AD and had an MMSE ≥20. Using corrections for specificity of clinical diagnosis of AD, we estimated that about 50 000 (9.1%) had a prodromal or mild AD. In the combined electronic clinical records database of 11 French expert memory centres, a diagnosis of prodromal or mild AD, certified by the use of cerebrospinal fluid AD biomarkers, could be established in 195 (1.3%) out of 14 596 patients.

CONCLUSIONS:

AD was not frequently diagnosed at a prodromal or mild dementia stage in France in 2014 to 2018. Diagnosis rarely relied on a pathophysiological marker even in expert memory centres. National databases will be valuable to monitor early stage AD diagnosis efficacy in memory centres when a disease-modifying treatment becomes available.

KEYWORDS:

National database; epidemiology; mild Alzheimer’s disease; mild cognitive impairment; prodromal Alzheimer’s disease

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