Mild Cognitive ImpairmentNCT00979446
Passport to Brain Wellness in Sedentary Adults
A study testing Guided and Self-directed in people with Mild Cognitive Impairment and Alzheimer's Disease, run by HealthPartners Institute at 1 site in United States.
Trial summary
Numerous modifiable lifestyle factors have been identified that may affect the risk of older adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence suggests that interventions to reduce risk factors and enhance protective factors would be beneficial in slowing cognitive decline and… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Guided and Self-directed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between the ages of 60 and 80
- Have had HealthPartners insurance for 11 out of the 12 months prior to recruitment
- Engage in less than 90 minutes per week of moderate intensity physical activity
- Works or volunteers 20 hours total per week or less
- Telephone Interview for Cognitive Status (TICS) score of 31 and above
Who cannot join
- Modified Charlson scores >=3 (calculated using prior year diagnoses)
- Nonskin cancer
- Congestive heart failure
- Coronary heart disease
- Psychotic Illness
- Substance abuse
- Terminal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Bloomington, Minnesota, 55425
About this study
Official title: Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80
Numerous modifiable lifestyle factors have been identified that may affect the risk of older adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence suggests that interventions to reduce risk factors and enhance protective factors would be beneficial in slowing cognitive decline and decreasing the risk of incident MCI and AD. The overall objective of this pilot study, funded as a supplement to Keep Active Minnesota (KAM) (03-024; R01-AG023410) is to develop and test the feasibility of conducting a multi-domain intervention to maintain cognitive health in adults ages 60-80 with the goal of reducing the incidence of and slowing progression to MCI and other more severe forms of cognitive decline.
Read the detailed description
The initial aim of the project was to recruit 20 cognitively intact adults ages 60-80 from one health plan, assessing them at baseline with respect to their cognitive health, multiple lifestyle factors, biomarkers and biometrics, engaging them in a 12 week lifestyle intervention and re-assessing them immediately post-intervention.
Specific Aims
- Design a multi-domain, lifestyle intervention to increase PA, social integration and cognitive stimulation, and improve nutrition in sedentary, cognitively intact adults, age 60 to 80.
- Assess the feasibility of implementing such a multi-domain intervention:
- recruit and screen 20 sedentary, cognitively intact adults aged 60 to 80 from a health plan,
- obtain baseline measures of cognitive function, physical and social activities, mood, nutrition, height and weight, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation,
- engage these adults in a 4 month pilot of this multi-domain lifestyle intervention with a phone coach and
- obtain post-intervention measures of cognitive functioning, physical and social activities, mood, nutrition, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation.
After successfully recruiting the first 20 subjects, we determined that the grant budget would allow us to enrich the study by recruiting 40 more subjects. A second, comparison arm was added. The first study arm received the intervention as described above. Subjects assigned (by chance) to the comparison arm received study materials but did not have a phone coach assigned. The additional 40 subjects were genotyped with respect to the apolipoprotein E4 (apoE4) allele.
This feasibility pilot of an evidence-based intervention targets protective lifestyle factors related to cognitive health, including physical and social activities, cognitive stimulation and nutrition. The information gained on intervention design, implementation, and subject recruitment, will guide development of a full-scale intervention study of primary prevention of cognitive decline.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Guided, Self-directed
- Keywords
- Interactive phone-based intervention with written materials, Older adults, Physical activity, Cognitive stimulation, Social engagement
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuidedBehavioural
Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach
Self-directedBehavioural
Received study materials but no phone coaching
| Study group | Role | What they receive |
|---|---|---|
| Guided | Experimental | Not described Receives: Behavioral: Guided |
| Self-directed | Active comparator | Not described Receives: Behavioral: Self-directed |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.
Measured: Six months after the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Investigators
- Brian C Martinson, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979446
- Sponsor's protocol ID
- 03-024S2
- Other IDs
- 3R01AG023410-05S2
- Status last verified
- Sep 2009
- First submitted
- 16 Sep 2009
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80
- ClinicalTrials.gov ID
- NCT00979446
- Acronym / sponsor ID
- 03-024S2
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- Interactive phone-based intervention with written materials, Older adults, Physical activity, Cognitive stimulation, Social engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous modifiable lifestyle factors have been identified that may affect the risk of older adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence suggests that interventions to reduce risk factors and enhance protective factors would be beneficial in slowing cognitive decline and decreasing the risk of incident MCI and AD. The overall objective of this pilot study, funded as a supplement to Keep Active Minnesota (KAM) (03-024; R01-AG023410) is to develop and test the feasibility of conducting a multi-domain intervention to maintain cognitive health in adults ages 60-80 with the goal of reducing the incidence of and slowing progression to MCI and other more severe forms of cognitive decline.
Detailed description
The initial aim of the project was to recruit 20 cognitively intact adults ages 60-80 from one health plan, assessing them at baseline with respect to their cognitive health, multiple lifestyle factors, biomarkers and biometrics, engaging them in a 12 week lifestyle intervention and re-assessing them immediately post-intervention.
Specific Aims
- Design a multi-domain, lifestyle intervention to increase PA, social integration and cognitive stimulation, and improve nutrition in sedentary, cognitively intact adults, age 60 to 80.
- Assess the feasibility of implementing such a multi-domain intervention:
- recruit and screen 20 sedentary, cognitively intact adults aged 60 to 80 from a health plan,
- obtain baseline measures of cognitive function, physical and social activities, mood, nutrition, height and weight, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation,
- engage these adults in a 4 month pilot of this multi-domain lifestyle intervention with a phone coach and
- obtain post-intervention measures of cognitive functioning, physical and social activities, mood, nutrition, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation.
After successfully recruiting the first 20 subjects, we determined that the grant budget would allow us to enrich the study by recruiting 40 more subjects. A second, comparison arm was added. The first study arm received the intervention as described above. Subjects assigned (by chance) to the comparison arm received study materials but did not have a phone coach assigned. The additional 40 subjects were genotyped with respect to the apolipoprotein E4 (apoE4) allele.
This feasibility pilot of an evidence-based intervention targets protective lifestyle factors related to cognitive health, including physical and social activities, cognitive stimulation and nutrition. The information gained on intervention design, implementation, and subject recruitment, will guide development of a full-scale intervention study of primary prevention of cognitive decline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided | Experimental | Behavioral: Guided |
| Self-directed | Active comparator | Behavioral: Self-directed |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults between the ages of 60 and 80
- Have had HealthPartners insurance for 11 out of the 12 months prior to recruitment
- Engage in less than 90 minutes per week of moderate intensity physical activity
- Works or volunteers 20 hours total per week or less
- Telephone Interview for Cognitive Status (TICS) score of 31 and above
Key exclusion criteria (7 listed)
- Modified Charlson scores >=3 (calculated using prior year diagnoses)
- Nonskin cancer
- Congestive heart failure
- Coronary heart disease
- Psychotic Illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuidedEngaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach | Behavioural | Guided |
| Self-directedReceived study materials but no phone coaching | Behavioural | Self-directed |
Primary outcome
We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.
Time frame: Six months after the baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
Related trials for Mild Cognitive Impairment
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Enrolling by invitation
Mild Cognitive Impairment and Neuromodulation
Mild Cognitive Impairment (MCI)
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C Martinson, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided and Self-directed in people with Mild Cognitive Impairment and Alzheimer's Disease, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention. (time frame: Six months after the baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2009; AzTrials last refreshed its copy on 6 Nov 2026.