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Michael R

FINGER Trial: Cognitive Decline in Older Adults Slowed by Diet, Exercise, Cognitive Training, Risk Monitoring

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This is the first clinical trial to show that a comprehensive prevention intervention can slow the rate of cognitive decline in the normal elderly. The guidance here is consistent with the epidemiology and generally-accepted health advice, of course, but that's exactly why the trial was structured this way: (a) because you want to try what you think is grounded in evidence, but also ( B) the very fact that everyone is assuming that this is the way to go and that it's being widely recommended makes it all the more important to actually test it.
 

Lancet. 2015 Mar 11. pii: S0140-6736(15)60461-5. doi: 10.1016/S0140-6736(15)60461-5. [Epub ahead of print]
A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial.
Ngandu T1, Lehtisalo J2, Solomon A3, Levälahti E2, Ahtiluoto S2, Antikainen R4, Bäckman L5, Hänninen T6, Jula A2, Laatikainen T7, Lindström J2, Mangialasche F5, Paajanen T8, Pajala S9, Peltonen M2, Rauramaa R10, Stigsdotter-Neely A11, Strandberg T12, Tuomilehto J13, Soininen H14, Kivipelto M METHODS:

In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys. Inclusion criteria were http://www.jfponline.com/fileadmin/content_pdf/cnn/archive_pdf/vol3iss4/70130_main.pdf of at least 6 points and cognition at mean level or slightly lower than expected for age. We randomly assigned participants in a 1:1 ratio to a 2 year multidomain intervention (diet, exercise, cognitive training, vascular risk monitoring), or a control group (general health advice). ...

[iNTERVENTIONS]: Participants were advised to consume a diet with 10–20% of daily energy from proteins, 25–35% daily energy from fat (<10% from saturated plus trans fatty acids, 10–20% from monounsaturated fatty acids, and 5–10% from polyunsaturated fatty acids [including 2·5–3 g/day of omega-3 fatty acids]), 45–55% daily energy from carbohydrates (<10% from refined sugar), 25–35 g/day of dietary fibre, less than 5 g/day of salt, and less than 5% daily energy from alcohol. Energy intake facilitating 5–10% reduction in body weight was recommended only if necessary after taking into account BMI, health status, age, and diet of the participant. These goals were achieved by recommendation of high consumption of fruit and vegetables, consumption of wholegrain cereal products and low-fat milk and meat products, limiting of sucrose intake to less than 50 g/day, use of vegetable margarine and rapeseed oil instead of butter, and fish consumption at least two portions per week. …

Training was guided by study physiotherapists at the gym and consisted of individually tailored programmes for progressive muscle strength training (1–3 times per week) and aerobic exercise (2–5 times per week), including exercises to improve postural balance. The strength training programme was standardised to include exercises for the eight main muscle groups …

Cognitive training included group and individual sessions. The ten group sessions were led by psychologists: six sessions with educational content on age-related cognitive changes, memory, and reasoning strategies applied to everyday activities, and four sessions for checking progress in individual computer-based training plus a visit to the local Alzheimer Association. Individual sessions consisted of computer-based training at home or at study site, conducted in two periods of six months each. ... The training programme was a web-based in-house developed computer program including several tasks adapted from protocols previously shown to be effective in shorter-term randomised controlled trials: 24 executive processes (updating spatial, updating letter, updating number, and mental set shifting tasks), working memory (maintenance task), episodic memory (relational and spatial tasks), and mental speed (shape match task).

Social activities were stimulated through the numerous group meetings ... Management of metabolic and vascular risk factors [not directly spelled out, but certainly included blood pressure and anthropometry, and screening included lipids, blood pressure, plasma glucose (fasting and 2 h OGTT), BMI, and depressive symptoms -MR] was based on national evidence-based guidelines. ... It included additional meetings with the study nurse (at 3, 9, and 18 months), and the study physician (at 3, 6, and 12 months) for [retesting a subgroup of indicators, and]... recommendations for lifestyle management. Study physicians did not prescribe medication, but strongly recommended participants to contact their own physician or clinic if needed. ...

Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation. The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery (NTB) Z score [The NTB is a cognitive function test that appears to be more sensitive than the long-used ADAS-Cog test as an assay for cognitive decline in people whose cogntive function is relatively intact, thus making it more appropriate for testing interventions in people with preclinical or mild/early AD -MR].

FINDINGS:
... we screened 2654 individuals and randomly assigned 1260 to the intervention group (n=631) or control group (n=629). 591 (94%) participants in the intervention group and 599 (95%) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis.

Estimated mean change in NTB total Z score at 2 years was 0·20 (SE 0·02, SD 0·51) in the intervention group and 0·16 (0·01, 0·51) in the control group. Between-group difference in the change of NTB total score per year was 0·022 (95% CI 0·002-0·042, p=0·030). [This is quite surprising: normally, cognitive function DECLINES in aging people, and esp. people whose cognitive function is lower than normal; here, instead, both the controls AND the intervention groups actually improved over the course of 2 y for the group as a whole. There is surprisingly little note taken of this in the paper, tho' they do mention the possibility that practice effects on the test itself may have contribute. Notable IAC is that Table 2 reports "Risk of cognitive decline from baseline to 24 months", and shows that people assigned to the intervention group were ≈24% less likely to suffer decline over the next two years -MR].

153 (12%) individuals dropped out overall. Adverse events occurred in 46 (7%) participants in the intervention group compared with six (1%) participants in the control group; the most common adverse event was musculoskeletal pain (32 [5%] individuals for intervention vs no individuals for control). [My guess is that this was related to injuries from exercising -MR].

INTERPRETATION:
Findings from this large, long-term, randomised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population.

PMID: 25771249

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