Clinical trial NCT01513252: Long-term Effects of Interventional Strategies to Prevent Cognitive Decline in Elderly.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Cognitive decline
prevention
omega-3 fatty acids
nutrition exercise
cognitive training
social activities
frailty
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 1028
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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, n=420 each) and a placebo group (n=420). 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 mg/day);
* 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).

Eligibility criteria: Inclusion Criteria:

Subjects who meet the following criteria will be included in the MAPT PLUS study :

* frail elderly subjects participating in the MAPT study and still followed at 3 years,
* subjects capable of understanding the protocol, complying with its requirements and attending the follow-up visits proposed as part of the extended phase of the MAPT study,
* subjects capable of giving their written informed consent and complying with the requirements of the study,
* subjects covered by a health insurance system.

Exclusion Criteria:

Subjects who fulfill at least one of the following criteria will not be included in the MAPT PLUS study :

* known presence of dementia or Alzheimer's disease (DSM IV criteria) diagnosed during the MAPT follow-up,
* known presence of severe diseases that are life-threatening in the short term,
* visual or hearing impairments that are incompatible with performance and/or interpretation of the neuropsychological tests,
* history and/or presence of any disorder (severe depression or generalized anxiety) which, according to the investigator, is likely to interfere with the results of the study or to expose the subject to a supplementary risk,
* participation in another clinical study during the period of the present study,
* subjects who have refused cognitive evaluation during the MAPT follow-up,
* subjects deprived of their freedom by administrative or judicial decision, or under guardianship,
* with regard to performance of MRI: presence of a pacemaker or metallic materials, claustrophobia.

Primary outcomes:
measure: Gröber and Buschke test (spontaneous delayed recall score)
timeFrame: 2 years
measure: Cognitive and functional performance (Gröber and Buschke test-spontaneous delayed recall score)
timeFrame: 2 years
Secondary outcomes:
measure: MRI test
timeFrame: 2 years
measure: Cost-effectiveness Evaluation
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux
city: Castres
country: France
facility: CH Castres-Mazamet
city: Dijon
country: France
facility: CHRU Dijon
city: Foix
country: France
facility: CHIVA
city: Lavaur
country: France
facility: LAVAUR
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Lyon-Sud Hospital
city: Montauban
country: France
facility: Chg Montauban
city: Montpellier
country: France
facility: CHU Montpellier
city: Nice
country: France
facility: Nice
city: Tarbes
country: France
facility: Tarbes
city: Toulouse
country: France
facility: UH Toulouse - La Grave
city: Monaco
country: Monaco
facility: CH Princesse Grâce
Study officials:
affiliation: University Hospital, Toulouse
name: Bruno Vellas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takano E, Maltais M, Kondo I, Rolland Y; MAPT/DSA group. Bidirectional relationship between depressive symptoms and physical performance in community-dwelling older people with subjective memory complaints. Eur Geriatr Med. 2021 Oct;12(5):973-980. doi: 10.1007/s41999-021-00473-9. Epub 2021 Mar 5.
citation: Delrieu J, Voisin T, Saint-Aubert L, Carrie I, Cantet C, Vellas B, Payoux P, Andrieu S. The impact of a multi-domain intervention on cerebral glucose metabolism: analysis from the randomized ancillary FDG PET MAPT trial. Alzheimers Res Ther. 2020 Oct 19;12(1):134. doi: 10.1186/s13195-020-00683-6.
citation: Delrieu J, Payoux P, Carrie I, Cantet C, Weiner M, Vellas B, Andrieu S. Multidomain intervention and/or omega-3 in nondemented elderly subjects according to amyloid status. Alzheimers Dement. 2019 Nov;15(11):1392-1401. doi: 10.1016/j.jalz.2019.07.008. Epub 2019 Sep 23.
citation: Pothier K, de Souto Barreto P, Maltais M, Rolland Y, Vellas B. Shifting from Declines to Improvements: Associations between a Meaningful Walking Speed Change and Cognitive Evolution over Three Years in Older Adults. J Nutr Health Aging. 2018;22(10):1183-1188. doi: 10.1007/s12603-018-1059-8.
citation: Lilamand M, Cesari M, Cantet C, Payoux P, Andrieu S, Vellas B; the MAPT/DSA study group. Relationship Between Brain Amyloid Deposition and Instrumental Activities of Daily Living in Older Adults: A Longitudinal Study from the Multidomain Alzheimer Prevention Trial. J Am Geriatr Soc. 2018 Oct;66(10):1940-1947. doi: 10.1111/jgs.15497. Epub 2018 Sep 12.