NCT07732842

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jun 2021Feb 2027

Study Start

First participant enrolled

June 24, 2021

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

5.7 years

First QC Date

July 23, 2026

Last Update Submit

September 7, 2026

Conditions

Keywords

Repetitive behavior

Outcome Measures

Primary Outcomes (1)

  • Characterize the type of repetitive behaviour (RB) observed in AD and estimate its frequency in this disease

    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

Secondary Outcomes (2)

  • Investigate cognitive characteristics in Alzheimer's disease patients that explain the presence or absence of repetitive behaviour (RB).

    At enrollment

  • Investigate the possible link between repetitive behavior and anosognosia.

    At enrollment

Study Arms (4)

Patients with repetitive behavior (RB+)

Patients without repetitive behavior (RB-)

Control group

Patient with anterograde amnesia (AA)

Patient with anterograde amnesia , resulting from complications following neurosurgery (non-Alzheimer Disease patient).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • I- RB+ (n=42) and RB- (n=30) groups :
  • MMSE \> 20
  • reliable family caregiver identified per patient
  • Patients under legal protection (guardianship/curatorship) or not
  • Selection:
  • 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)
  • Healthy subjects
  • MMSE ≥ 26/30
  • Men and women matched to AD patients in terms of age and sociocultural level.
  • Healthy subjects will be included by the CMRR in Limoges
  • III- Control group: Patient with anterograde amnesia (AA) (n=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.
  • This patient is under legal protection (guardianship).
  • Patient monitored and included at the CMRR in Limoges.

You may not qualify if:

  • Isolated participants (without an identified caregiver) (RB+ and RB- groups)
  • Participants must not have a history of alcohol or other substance dependence in the past 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esquirol Hospital Center

Limoges, New Aquitaine, 87025, France

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseAmnesia, AnterogradeAgnosia

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersAmnesiaMemory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual Disorders

Central Study Contacts

Clément POLIN, PhD neuropsychology

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 29, 2026

Study Start

June 24, 2021

Primary Completion (Estimated)

February 24, 2027

Study Completion (Estimated)

February 24, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations