Striatum and Hippocampus on Different Time Scales

Alzheimer Disease Clinical Trial

— e-Time  

Official title:

Role of the Striatum and Hippocampus on Different Time Scales

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943054
• Other study ID #: APHP20211105
• Secondary ID: 2021-A01008-33
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: July 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Anne-Catherine BACHOUD-LEVI, MD, PhD
• Phone: 01 49 81 23 10
• Email: anne-catherine.bachoud-levi[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Time processing is fundamental to survival and goal reaching in humans. Different time scales (seconds, minutes, and beyond) are processed through specific cognitive processes involving different neural representations. It is generally agreed that time scale in seconds-to-minutes range named "interval timing" would be anatomically linked to the striatum. Indeed, it is possible to demonstrate a deficit of interval timing processes in patients suffering from striatal damage (Huntington's disease). However, recent findings show involvement of a second brain structure, the hippocampus, in interval timing processing in the minutes range, suggesting an interaction between the striatum and hippocampus. Presumably, patients with hippocampal damage (Alzheimer's disease) would specifically show a decrease in performance for this minutes-range time scale. This study aims to provide a better understanding of the role of the striatum in the treatment of time and its interactions with other brain structures such as the hippocampus. More specifically, it is unclear whether the striatum plays a platform role that would always be involved regardless of the time scale, as suggested by the unified model of time or whether different brain structures is solicited according to the time scale, as suggested by the modular system model. In order to elucidate these issues, a potential double dissociation between brain structures and time scales will be tested.

Description:

In that aim, we will evaluate patients with Huntington's disease and patients with Alzheimer's disease by developing and using time processing paradigms comparing short and long time scales.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Huntington's disease gene carriers
• Patient included in the BioHD protocol
• Age from 18 to 90 years old
• Symptomatic patient
• TFC = 11
• UHDRS motor> 5
• Native language: French
• Affiliation to a social security or to another social protection
• Signature of informed consent
• Patients with Alzheimer's disease
• MMS from 20 to 26 (included)
• Age: from 60 to 90 years old
• Native language: French
• Progressive deterioration of memory reported by patient or caregiver for more than 6 months
• Profile at RL /RI 16: no significant improvement with indexing
• Episodic memory disorder isolated or associated with other cognitive disorders
• MRI: Atrophy of the median temporal lobe
• Affiliation to a social security or to another social protection
• Signature of informed consent
• Healthy subjects
• Healthy subject included in the BioHD protocol
• MMS = 26
• Age from 18 to 90 years old
• Native language: French
• Affiliation to a social security or to another social protection
• Signature of informed consent

Exclusion Criteria:

• Huntington's disease gene carriers
• Intellectual deterioration preventing understanding of the protocol
• Other dementia than Huntington's disease
• Patient living alone at home
• Major depression
• Patient under legal protection
• Patient deprived of liberty
• Pregnant or breastfeeding woman, situation known to the investigator
• Inability to handle an electronic tablet
• Patients with Alzheimer's disease
• Intellectual deterioration preventing understanding of the protocol
• Patient living alone at home
• Sudden onset of memory impairment
• Early onset of the following symptoms: difficulty in walking, convulsions, changes in behavior
• Focal neurological characteristics including hemiparesis, sensory loss, visual field deficit
• Early extrapyramidal sign
• Other dementia than Alzheimer's disease
• Major depression
• Cerebrovascular disease
• Toxic, metabolic or infectious anomaly
• Patient under legal protection
• Patient deprived of liberty
• Pregnant or breastfeeding woman, situation known to the investigator
• Inability to handle an electronic tablet
• Healthy subjects
• Intellectual deterioration preventing understanding of the protocol
• Known neurological or psychiatric illness
• Patient under legal protection
• Subject deprived of liberty
• Pregnant or breastfeeding woman, situation known to the investigator
• Inability to handle an electronic tablet

Related Conditions & MeSH terms

• Alzheimer Disease
• Huntington Disease

Intervention

Other:
• Temporal perception tasks
A "long" temporal perception task in which the duration of the stimulus, around 2 min, is materialized by a video. For each trial, two videos are displayed to the participants, and then the task of the participant is to indicate the longest video and to give his level of confidence in his answer. A "short" temporal perception task which will take place in the same way as the "long" task except that the duration of the stimulus, around 2 seconds, is materialized by still frames from the videos used in the previous task.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to discriminate durations	Ability to discriminate durations of a few seconds and durations of the order of minutes	25 months and 10 days
Secondary	Risks's prediction of temporal disorientation.	Analysis of the answers (true/false) to the questionnaire assessing temporal orientation in daily life	26 months
Secondary	Identification of neural correlations with temporal perception tests	Brain magnetic resonance imaging analysis	27 months