Becky McCall

March 12, 2012

March 12, 2012 (London, United Kingdom) — Interim results from a multidomain interventional study that has the aim of preventing cognitive impairment and disability by managing vascular and lifestyle risk factors show successful reductions in weight, body mass index (BMI), and low-density lipoprotein (LDL) cholesterol levels in patients at risk for dementia, researchers report.

Miia Kivipelto, MD, professor of clinical geriatric epidemiology from the Karolinska Institute in Stockholm, Sweden, is leading the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) trial, working with colleagues from the University of Eastern Finland in Kuopio and the University of Helsinki, Finland. She presented these 1-year results of the FINGER study here at the Alzheimer's Disease International (ADI) 27th International Conference.

Dr. Kivipelto pointed out that their results show it is possible to influence people to change their lifestyle. "I think these results are quite encouraging because they clearly show that people in the multidomain intervention group have significantly reduced weight, BMI, LDL cholesterol, and we also see an improving trend in glucose metabolism as well," she told Medscape Medical News.

"There's an urgent need to turn observation into action in prevention of dementia," Dr. Kivipelto said. In the light of so few currently available treatments for Alzheimer's disease, she added, "prevention is a key issue at the moment. Even if we can just postpone Alzheimer's, this would have a huge impact for the person and for public health."

She presented these findings at the final plenary session of the conference, stimulating debate on whether prevention of Alzheimer's disease is possible.

FINGER Study: "Prevention Is Key"

FINGER has 1,200 participants, aged between 60 and 77 years, drawn from 2 previous population-based noninterventional studies (the Finland Cardiovascular Risk Study [FINRISK] and the National Type 2 Diabetes Prevention Programme in Finland [Fin-D2D]). The participants were divided equally between the intervention and control arms of the study, which is being conducted in 6 centers across Finland.

Selection was carried out according to patients' risk of developing dementia, determined on the basis of a dementia risk score and a vascular risk factor profile at midlife. At baseline, mean BMI was 30, and 40% of participants had impaired glucose tolerance. These criteria provided an at-risk population most likely to benefit from the interventions used in the study. Patients were excluded if they already had a clear diagnosis of dementia.

"We are using the latest evidence on dementia and vascular risk factors for each of these interventions," said Dr. Kivipelto. "By incorporating all available information about risk factors and integrating these into a multidomain program, we hope to obtain the optimum preventative effect."

There are 4 main components to the intervention program: nutrition; exercise involving muscle strength training and aerobics; cognitive training, both individually and in groups; and effective monitoring and management of all metabolic and vascular risk factors through 3-monthly nurse visits. Interventions are adjusted to suit each participant's level of difficulty.

The primary outcome is change in cognitive impairment as measured by neuropsychological tests that are sensitive to early Alzheimer changes. Trail making and strobe tests are also being used as means of monitoring executive dysfunction, which is common in vascular cognitive impairment.

Secondary endpoints include dementia (after extended follow-up), disability, depressive symptoms, vascular risk factors and outcomes, biomarkers, quality of life, utilization of health resources, and, for a subgroup, changes on neuroimaging. "This is important because this way we are obtaining a picture of the total benefit of the intervention, and we will also learn about the mediating pathways in dementia," pointed out Dr. Kivipelto.

At 12 months, total cholesterol levels dropped from 5.13 mmol/L to 5.05 mmol/L in the intervention arm vs an increase from 5.12 to 5.19 in the control arm. These results are statistically significant (P = .04). LDL cholesterol dropped from 3.07 to 3.04 vs a rise of 3.06 to 3.15 in control participants. In the intervention group, a statistically significant drop in weight from 81.8 kg to 80.6 kg was seen; in the control group, weight dropped from 81.9 kg to 81.6 kg.

Dr. Kivipelto added that it was hoped these positive results would also be reflected by the cognitive tests at the end of the intervention period. "Regarding cognitive findings, I hope we will see a trend for differences after 2 years, but the aim is to follow these participants up to 7 years, and at that stage, I think there will be a greater opportunity to see the real differences," she commented.

Dr. Kivipelto noted the importance of regarding Alzheimer's as a multifactorial disease. "Multidomain intervention is the way to go because it reflects the nature of the disease.There are many negative results from studies looking at single agents. On a positive note, if there are many risk factors, it may be sufficient to reduce the level of these risk factors only slightly, and this will have a positive effect."

Low Dropout

Edo Richard, MD, PhD, neurologist from the University of Amsterdam in the Netherlands, commented on the interim results.

"I think it's an interesting study because they have such extensive baseline data, including midlife data on the participants," he told Medscape Medical News. "The preliminary findings on surrogate parameters such as BMI and cholesterol are definitely encouraging. Also, it's impressive that dropout levels are so low, because it is often difficult to ask elderly people to participate in physical exercise and cognitive challenges, but this work shows they actually enjoy participating in the study," he remarked.

Dr. Richard is conducting the Prevention of Dementia by Intensive Vascular Care (PreDIVA) study, a 6-year multicomponent interventional study, which shares the objective of the FINGER and the Multidomain Alzheimer Preventive Trial (MAPT) studies by aiming to prevent dementia.

"We hope we can learn rather than compete with each other. We are planning shared analysis when possible later in the process. The recently launched European Dementia Prevention Initiative is certainly an important first step toward more intensive international collaboration," he concluded.

Dr. Kivipelto and Dr. Richard have disclosed no relevant financial relationships.

Alzheimer's Disease International (ADI) 27th International Conference. Abstract OC108. Presented Saturday, March 10, 2012.



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