Clinical trial NCT04606420: Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
Official title: Lifestyle Intervention for Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Mild Cognitive Impairment
Lead sponsor: Preventive Medicine Research Institute
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Harvard Medical School (HMS and HSDM)
name: University of California, San Diego
name: The Cleveland Clinic
name: Renown Health
First posted: 2020-10-28
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In this randomized crossover design, 51 patients with early Alzheimer's disease were randomly-assigned to one of two groups. After baseline testing, the first group receives the lifestyle program for 20 weeks (via Zoom since 2/20 due to COVID-19). The second group does not and is a randomized control group during this phase. Both groups are re-tested after 20 weeks. Then, the second group "crosses over" and receives this program for 20 weeks and the first group continues the program for 20 additional weeks. After 40 weeks, both groups are re-tested again. Patients initially randomly assigned to the control group will receive the intervention for a total of 40 weeks and then be re-tested.

Due to challenges in recruiting patients, including Covid-19, we recently terminated recruitment after 51 patients were recruited. This decision was based on recruitment and funding issues, without review of any of the data. This trial will continue until all 51 patients have completed it.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine if comprehensive lifestyle changes may slow, stop, or reverse the progression of early-stage Alzheimer's disease.

Detailed description: 51 patients who have early Alzheimer's disease (MoCA above 17) in the San Francisco Bay area were enrolled over time and are randomly assigned to one of two groups.

After baseline testing, the first group then receives this lifestyle medicine program for 20 weeks, four hours/day, three days/week (all done virtually via Zoom since March 2020 due to COVID-19).

The second group will not receive the lifestyle program for 20 weeks and will serve as a randomized control group during this phase of the study.

Both groups will be re-tested after 20 weeks.

Then, the second group will "cross over" and receive this lifestyle medicine program for 20 weeks and the first group will continue the lifestyle program for 20 additional weeks. After a total of 40 weeks, both groups will be re-tested again and compared. Those initially randomly assigned to the control group will receive the intervention for 40 weeks and then be re-tested at that time.

Eligibility criteria: Inclusion Criteria:

* Current diagnosis of mild dementia or mild cognitive impairment due to Alzheimer's disease/process (McKhann and Albert criteria), with MoCA score above 17 (i.e., 18 or higher)
* Willingness and ability to participate in all aspects of the intervention
* Availability of spouse or caregiver who can provide collateral information and assist with study adherence

Exclusion Criteria:

* severe dementia
* physical disability that precludes regular exercise
* clear evidence for other causes of neurodegeneration or dementia, e.g., severe cerebrovascular disease, Parkinson's disease
* significant ongoing psychiatric or substance abuse problems

Primary outcomes:
measure: Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Change from Baseline in Clinical Global Impression of Change (CGIC) score
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score
timeFrame: At baseline and also after 20 weeks, 40 weeks.
Secondary outcomes:
measure: Changes from baseline in the microbiome
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Changes from baseline in telomere length
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Changes from baseline in biomarkers
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Inflammatory biomarkers
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Amyloid peptides
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: R-PLEX measures
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Angiogenesis biomarkers
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Vascular injury panel 2
timeFrame: At baseline and also after 20 weeks, 40 weeks.
measure: Metabolic Panel: 1 Human 7-PLEX
timeFrame: At baseline and also after 20 weeks, 40 weeks.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Sausalito
country: United States
facility: Preventive Medicine Research Institute
state: California
city: Boston
country: United States
facility: McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
state: Massachusetts
city: Reno
country: United States
facility: Renown Health Institute of Neurosciences
state: Nevada
Study officials:
affiliation: President, Preventive Med Res Inst; Clinical Prof Medicine UCSF
name: Dean Ornish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chief Neurologist, Preventive Medicine Research Institute
name: Catherine Madison, MD
role: STUDY_DIRECTOR
affiliation: Co-Director, McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
name: Rudolph E Tanzi, PhD
role: STUDY_DIRECTOR
affiliation: Director, Alzheimer's Clinical and Translational Research Unit, Harvard Medical School/Mass General Hospital
name: Steven E. Arnold, MD
role: STUDY_DIRECTOR
affiliation: Kistler Endowed Chair in Neurology, Harvard Medical School/Mass General Hospital
name: Jonathan Rosand, MD
role: STUDY_DIRECTOR
affiliation: Professor of Neurology, University of California, San Diego
name: Douglas Galasko, MD
role: STUDY_DIRECTOR
affiliation: Co-Director, Paul Glenn Labs for the Biology of Aging, Harvard Medical School
name: David A Sinclair, PhD
role: STUDY_DIRECTOR
affiliation: Renown Health Institute of Neurosciences
name: Jonathan Artz, MD
role: STUDY_DIRECTOR
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