Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01513252
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2011-12-30
Brief Title:
Long-term Effects of Interventional Strategies to Prevent Cognitive Decline in Elderly
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
A 2-years Extension Study of MAPT Trial Evaluation of the Long Term Effects of Interventional Strategies to Prevent the Decline in Cognitive Functioning in Frail Older Adults
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAPT-PLUS
Brief Summary:
The MAPT PLUS study is a two-year extension of follow-up of the patients included in the MAPT preventive study after completion of the interventions Subjects in the four groups of the MAPT study will be prospectively followed MAPT is a multicentre randomised placebo-controlled study using a 4-group design with 3 treatment groups omega 3 alone multi-domain intervention alone omega 3 plus multi-domain intervention n420 each and a placebo group n420 The MAPT PLUS study will be an extension of the MAPT study and includes an annual follow-up for two years
Detailed Description:
The MAPT PLUS study is a follow-up of subjects initially included in an interventional study The follow-up that we propose in this request for funding does not involve any intervention but aims to assess the long-term effect of the interventions previously carried out during the three years of the MAPT study
Description of the interventions to which subjects are exposed during the first 3 years of follow-up MAPT study
In the MAPT study subjects are randomized into 4 groups
V0137 CA group 2 soft capsules of V0137 CA once a day 2 x 400 mgday
Multi-domain intervention group nutrition physical activity cognitive stimulation social activities placebo 2 soft capsules once a day
Multi-domain intervention group nutrition physical activity cognitive stimulation social activities V0137 CA 2 soft capsules once a day
Placebo group 2 soft capsules of placebo once a day Description of the multidomain intervention The multi-domain intervention consists of collective training sessions and a yearly personalized preventive consultation which aims to detect risk factors sensory disturbances difficulty in walking nutritional disturbances vascular risk factors and to set up management in collaboration with the general practitioner
The collective sessions take place in groups of 6 to 8 subjects In the first month two sessions a week are scheduled and in the second month one session a week The first two months correspond to the intensive programme Each session comprises 1 hour of cognitive training 45 minutes of information on physical activity and 15 minutes of dietary advice From the third month sessions are held monthly and aim to consolidate the key messages and to stimulate adherence to the programme The sessions are shorter 1 hour review of one of the domains of the intensive programme Booster sessions 2 hours are delivered at 12 and 24 months after the first sessions of the intensive programme Twenty-minute individual interviews also take place every 6 months with the leader of the training sessions 6 interviews in the course of 3 years
Description of the interventions to which subjects are exposed during the first 3 years of follow-up MAPT study
In the MAPT study subjects are randomized into 4 groups
V0137 CA group 2 soft capsules of V0137 CA once a day 2 x 400 mgday
Multi-domain intervention group nutrition physical activity cognitive stimulation social activities placebo 2 soft capsules once a day
Multi-domain intervention group nutrition physical activity cognitive stimulation social activities V0137 CA 2 soft capsules once a day
Placebo group 2 soft capsules of placebo once a day Description of the multidomain intervention The multi-domain intervention consists of collective training sessions and a yearly personalized preventive consultation which aims to detect risk factors sensory disturbances difficulty in walking nutritional disturbances vascular risk factors and to set up management in collaboration with the general practitioner
The collective sessions take place in groups of 6 to 8 subjects In the first month two sessions a week are scheduled and in the second month one session a week The first two months correspond to the intensive programme Each session comprises 1 hour of cognitive training 45 minutes of information on physical activity and 15 minutes of dietary advice From the third month sessions are held monthly and aim to consolidate the key messages and to stimulate adherence to the programme The sessions are shorter 1 hour review of one of the domains of the intensive programme Booster sessions 2 hours are delivered at 12 and 24 months after the first sessions of the intensive programme Twenty-minute individual interviews also take place every 6 months with the leader of the training sessions 6 interviews in the course of 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-A00764-37 | OTHER | ID-RCB | None |