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Study of Repetitive Behaviors in Alzheimer's Disease (ECRA)

7. september 2026 oppdatert av: Clément Polin, Centre Hospitalier Esquirol

Alzheimer's disease (AD) is characterized by anterograde amnesia, the inability to memorize and remember events occurring after the cerebral lesion. Among the most frequently reported psychobehavioral symptoms are repetitive behaviors (RBs), defined as actions or statements repeated in an inappropriate and non-functional way.

The most commonly used tool to assess repetitive behaviors is the Stereotypy Rating Inventory (SRI). It is a questionnaire that evaluates five types of stereotypical behavior: eating, wandering, speech, movements, and daily routines. The frequency and severity of the behaviors are reported, and a total score can be calculated.

There is no consensus on the types of repetitive behaviors observed specifically in AD, their frequency, or their cognitive correlates, nor is there a hypothesis explaining why these symptoms do not occur in all AD patients. Furthermore, certain parameters, such as anosognosia (lack of awareness of the disorders), have not been linked to RBs in the literature. We propose to evaluate patients with anterograde amnesia in terms of cognition and behavior-specifically, the presence or absence of both RBs and anosognosia-to examine possible links between cognitive performance, anosognosia, and RB.

Moreover, there is no theoretical framework explaining the emergence of RBs in amnesia. We suggest that RBs are linked to a lack of memory updating in the cognitive system. Since episodic memory no longer provides mnemonic feedback, previously encountered stimuli may trigger repeated behavior.

To test this hypothesis, we decided to conduct a multicenter, cross-sectional, case-control study. Patients with AD, with or without RBs, as well as healthy subjects, were repeatedly presented with sentence starters to complete freely, with the aim of studying the similarity of responses across sessions for each participant. We also included a patient with pure anterograde amnesia from a previously submitted case study protocol, who exhibited pronounced RBs symptomatology following neurosurgery (non-AD patient), to examine the phenomenon in a non-Alzheimer's context.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

103

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population consists of:

  • 42 patients RB+ and 30 patients RB- patients recruited at the CMRR in Limoges and Nantes during their follow-up appointments for Alzheimer's disease.
  • 30 healthy subjects who are caregivers for patients monitored at the CMRR in Limoges.
  • And the patient with AA anterograde amnesia, who was recruited as part of his follow-up at the CMRR in Limoges for his severe anterograde amnesia caused by brain damage to the fornix pillars following complications from neurosurgery.

Beskrivelse

Inclusion Criteria:

I- RB+ (n=42) and RB- (n=30) groups :

  1. MMSE > 20
  2. 1 reliable family caregiver identified per patient
  3. Patients under legal protection (guardianship/curatorship) or not
  4. Selection:

4.a. AD patients with an SRI score > 0 will constitute the RB+ subgroup. 4.b. Only the first 30 patients included will undergo V2, V3, and V4. The first 30 AD patients included with an SRI score = 0 will constitute the RB- subgroup.

II- Control group: healthy subjects (n=30)

  1. Healthy subjects
  2. MMSE ≥ 26/30
  3. Men and women matched to AD patients in terms of age and sociocultural level.
  4. Healthy subjects will be included by the CMRR in Limoges

III- Control group: Patient with anterograde amnesia (AA) (n=1):

  1. The patient with anterograde amnesia is a patient who participated in the ANISAAFORNIX study (another study submitted by the investigator) and is included in this study due to rich RB symptomatology. He is a 54-year-old man with lesions of the fornix following complications from neurosurgery, which led to severe anterograde amnesia. This patient does not have AD.
  2. This patient is under legal protection (guardianship).
  3. Patient monitored and included at the CMRR in Limoges.

Exclusion Criteria: I- RB+ and RB- groups and healthy subjects:

  1. Isolated participants (without an identified caregiver) (RB+ and RB- groups)
  2. Participants must not have a history of alcohol or other substance dependence in the past 12 months.
  3. Participants must not have any other neurological condition (with the exception of patients with AA anterograde amnesia). Any history of moderate to severe head trauma, stroke, or developmental disorders is a criterion for exclusion.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Kontrollgruppe
Patient with anterograde amnesia (AA)
Patient with anterograde amnesia , resulting from complications following neurosurgery (non-Alzheimer Disease patient).
Patients with repetitive behavior (RB+)
Patients without repetitive behavior (RB-)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease
Tidsramme: At enrollment
The repetitive behavior score is obtained using the Stereotypy Inventory Rating (SRI) scale after the participant has been included in the study. The five types of stereotypical behavioral disturbances: eating behaviors, wandering, speech, movements, and daily rhythms are collected. A score of zero means no repetitive behavior, and a score strictly above 0 means the presence of repetitive behavior.
At enrollment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Investigate cognitive characteristics in Alzheimer's disease patients that explain the presence or absence of repetitive behaviour (RB).
Tidsramme: At enrollment
Cognitive characteristics are based on scores obtained in the RL/RI16 cognitive tests, which assess learning abilities in verbal episodic memory, particularly the processes of encoding, storage, and retrieval. We believe that we will observe a difference of 2 points out of 16 on the "Recognition" subtest of the RL/RI-16 test between SRI-positive subjects and SRI-negative subjects.
At enrollment
Investigate the possible link between repetitive behavior and anosognosia.
Tidsramme: At enrollment

Investigate the possible link between repetitive behavior and anosognosia is based on a possible correlation between the scores obtained on the SRI, CDS, and MPR.

The CDS allows anosognosia to be assessed independently of the cognitive task. It contains a patient questionnaire and an helper questionnaire, which are compared, and a discrepancy between the two reflects anosognosia.

The Memory Performance Ratio (MPR) allows anosognosia to be assessed in a manner consistent with the cognitive task. Using a 5-point Likert scale, participants are asked to rate the quality of their performance. The pre- and post-dictions will be compared to the patient's actual performance, allowing a ratio to be established: the more accurate the participant is in their representation of their own performance, the lower the ratio will be. The further the participant's assessment is from their actual performance, the higher the ratio will be, indicating anosognosia.
At enrollment

Samarbeidspartnere og etterforskere

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Sponsor

Centre Hospitalier Esquirol

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. juni 2021

Primær fullføring (Antatt)

24. februar 2027

Studiet fullført (Antatt)

24. februar 2027

Datoer for studieregistrering

Først innsendt

23. juli 2026

Først innsendt som oppfylte QC-kriteriene

23. juli 2026

Først lagt ut (Faktiske)

29. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2021-A00631-40

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