Alzheimer's Disease Clinical Trials Program
Research Program in Healthy Brain Aging and Alzheimer’s Disease
As the largest research program in brain aging, memory loss and Alzheimer’s Disease in northern New England, Northern Light’s Alzheimer’s Disease Research Program is committed to bringing the latest diagnostic methods and experimental therapeutics to our region. We strive to have a broad spectrum of clinical trials from primary prevention to mild cognitive impairment to all stages of dementia.
We generally recruit from the Northern Light Acadia Hospital Mood and Memory Clinic, but accept referrals for trials from the community, especially for people with normal cognition who are concerned about developing dementia, and patients diagnosed with mild cognitive impairment or Alzheimer’s disease who are motivated to participate in a clinical trial without having to go to Boston.
Biomarker analysis provided by research protocols allow reseach subjects to learn of their risk for Alzheimer’s disease from amyloid or tau PET scans, CSF biomarkers or genotype. Experimental interventions include those aimed at reducing brain amyloid or tau levels, agents with putative neuroprotective effects or drugs that may enhance cognition or reduce psychiatric symptoms.
Healthy Brain Aging Registry
We are also starting a registry and longitudinal study for cognitive health and dementia (Maine Initiative for Neurologic Aging and Health or MAINAH) in collaboration with other investigators in our region. We hope to eventually bring an NIA-funded ADRC to Maine.
Open studies as of March 2019
Normal cognition (primary prevention)
Generations 1 (https://www.generationprogram.com/#Main): Sponsored by Novartis in collaboration with Banner Alzheimer’s Research Institute. Inclusion: APO Ɛ4/Ɛ4, age 60-74, MMSE ≥24, RBANS memory index ≥85 and CDR=0 or RBANS 70-84 and CDR=0.5, GDS<6, generally good health. RPCT with either placebo, amyloid vaccine or β-secretase inhibitor to reduce brain amyloid burden. Twice yearly visits for 8 years for safety and cognitive assessment. Amyloid and FDG-PET scans plus volumetric MRIs at baseline, years 2,5 & 8. Study partner needed for this and all studies.
Generation 2: Similar to above but for heterozygous APO Ɛ4 and only randomized to placebo or β-secretase inhibitor.
Normal cognition and MCI
Normal cognition and MCI: The Maine Initiative for Neurologic Aging and Health (MEINAH). This is an EMMC-funded registry and longitudinal study to develop a cohort of people who can serve all investigators in Maine interested in genotype/phenotype relationships in cognitive aging. We are partnering with Jackson Labs (and hopefully others) on this study.
Mild cognitive impairment: Disease modification/Anti-amyloid or neuroprotective
AZTherapies (https://aztherapies.com/): Phase 3 study of inhaled cromolyn sodium combined with ibuprofen to prevent aggregation of beta amyloid fibrils and reduce neuroinflammation. Wechsler Memory Scale ≤8 for those w ≥16 yrs education and ≤4 with less education, CDR=0.5, ages 55-79, positive CSF biomarkers for AD. RPCT with 4 treatment arms (1 arm with both active treatments, 1 with two placebos, etc.). Primary outcome is CDR-SOB at week 72.
Mild cognitive impairment: Symptomatic treatment
|Amyvid® scan showing amyloid deposition particularly heavy in frontal cortical gray matter.
MIND “Memory Improvement Through Nicotine Dosing” (http://mindstudy.org/): NIA-funded through the Alzheimer’s Therapeutic Research Institute at USC. Uses titrated doses of nicotine patches vs. placebo patches. Age ≥55-90, MMSE≥23, CDR-0.5, abnormal memory scores on Logical Memory II Delayed Paragraph Recall subscale. Primary outcome measure is Conners Continuous Performance Task change from baseline over 24-month study. Secondary are MCI-Clinical Global Impression of Change and neurocognitive outcomes are performance on volumetric MRI, Cogstate Battery, CDR-SOB and ADCS-ADL-MCI scale and GDS.
Mild to moderate dementia: Symptomatic and neuroprotective
T2 Protect AD (http://www.t2protect.org/): Sponsored by Biohaven and the NIA-funded Alzheimer’s Disease Cooperative Study at UCSD. This is a study of troriluzole, a glutamate modulator that may slow progression of AD or enhance cognition. This is a 48-week RPCT trial. Ages 50-85, MMSE=14-24. May be on AchEI or memantine. Primary outcome is ADAS-Cog 11. Secondary measures are CDR-SOB, volumetric MRI and a neuropsychological test battery. CSF biomarkers and genotype are also measured.
If you have any questions about a specific patient or just want to learn more about what trials are available in Maine, call or write us.
Lead Coordinator is Cindy Whited, RN, firstname.lastname@example.org, Office 207-973-7596 / Cell 207-735-4276
Principle Investigator is Cliff Singer, MD, email@example.com, Office 207-973-6100