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Age Related Cognitive DeclinePhase 2NCT01953705

n-3 PUFA for Vascular Cognitive Aging

A Phase 2 study testing Omega 3 PUFA in people with Age Related Cognitive Decline and Alzheimer's Disease, run by Oregon Health and Science University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Brain scans can help identify changes that appear to increase risk for cognitive decline and dementia. Some of these brain changes are thought to reflect actual damage to the small blood vessels that support normal brain function. Read more about this study

Who is it for?
Ages 75 years and olderHealthy volunteers can take part
What is being tested?
Omega 3 PUFA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteUnited States
Study dates
May 2014to Jun 2021
Phase
Phase 2
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 75 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Non-demented or mild cognitive impairment, defined as Clinical Dementia Rating =0 or 0.5 and MMSE >=24.
  • Age 75 and older, male and female
  • Total WMH volume ≥ 5 cc
  • Plasma PUFA index (EPA + DHA) < 110 ug/ml or < 5.5 weight percent
  • Sufficient English language skills to complete all tests
  • Geriatric Depression Scale - 15 < 6 documenting absence of a significant depressive syndrome
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  • Sufficient vision and hearing to complete all tests
  • Informant available with frequent (at least 1 hour/day or 1 day/week) contact with subject to verify functional status and CDR rating
  • General health status that will not interfere with the ability to complete the prospective study (these conditions are listed below in the study exclusion list)

Who cannot join

  • Any dementing illness (AD, vascular dementia, normal pressure hydrocephalus, or Parkinson's disease); dementia defined by CDR ≥ 1, MMSE < 24
  • Significant disease of the CNS such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis
  • Alcohol or substance abuse according to DSM-IV criteria within the last 2 years
  • Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-IV criteria
  • Abnormal labs indicating vitamin B12 deficiency, thyroid disease, or UTI (documented bacterial colonization is acceptable)
  • Unstable or significantly symptomatic CVD (e.g. CAD with frequent angina, CHF with dyspnea at rest)
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  • Hypertension: defined as uncontrolled BP > 150/90
  • Clinical symptomatic orthostatic hypotension
  • Diabetes mellitus that requires insulin injections
  • History of cortical stroke
  • Cancer within the last 5 years, with the exception of localized prostate cancer (Gleason Grade < 3) and non-metastatic skin cancers (melanoma).
  • Illness that requires >1 visit /month to a clinician
  • Contraindications to MRI (i.e., heart pacemaker, metal plates or objects in head, , claustrophobia)
  • Medications:
  • CNS active meds that have not been on stable doses for at least 2 months (cimetidine, beta-blockers, and SSRIs)
  • Neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics; in the case where these were used for a self-limited time they must have been discounted for a period of five half-lives prior to baseline visit
  • Over the counter supplements are not by themselves exclusionary, however, subjects are asked not to change the dosing regimen over the course of the trial unless medically indicated; the presence and dose of these agents are recorded
  • A baseline screen plasma PUFA > 5.5 weight percent of total fatty acids for EPA+DHA will confirm supplementation of O3PUFA history. If patient indicates regular supplementation with fish oil on phone screen, can wash out for 4 months prior to study visit one.
  • Cholinesterase inhibitors (i.e., Aricept)
  • Investigational drugs within five half-lives prior to baseline
  • Anticoagulation therapy: Vitamin K antagonist: warfarin (Coumadin, jantoven), Factor Xa inhibitors: rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis); Low molecular weight heparins: dalteparin (fragmin), enoxaparin (lovenox)(Incident use of anticoagulant therapy will exclude further study drug allocation. However, subjects will be asked to complete all follow-up visits.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Omega 3 PUFA for the Vascular Component of Age-related Cognitive Decline

Brain scans can help identify changes that appear to increase risk for cognitive decline and dementia. Some of these brain changes are thought to reflect actual damage to the small blood vessels that support normal brain function. This clinical trial will determine whether an omega 3 polyunsaturated fatty acid (PUFA) therapy can promote brain health by supporting the small blood vessels in the brain over 3 years in older adults at high risk for cognitive decline and dementia of Alzheimer's type.

Read the detailed description

The main objective of this study is to determine if omega 3 PUFA can slow the accumulation of brain MRI derived white matter hyper-intensities (WMH) over 3 years in a population at risk for dementia. This trial is designed to collect preliminary data into the mechanism by which PUFA therapy operates on the brain with special attention to the vascular components.

The randomized, double-blind and controlled trial will rigorously test PUFA effects versus a placebo in non-demented elders over 3 years. This biomarker based trial will enroll 100 elders. Aim 1 will assess PUFA effects on neuroimaging parameter changes. Aim 2 will assess PUFA effects on blood-based biomarkers of endothelial health, and Aim 3 will collect preliminary data on PUFA effects on neuropsychological and functional parameters with special attention to the executive and speed of processing skills and gait speed.

Being tested
Omega 3 PUFA, Placebo
Keywords
omega 3 fatty acids, cognitive decline, MRI, endothelial function, white matter, executive function, prevention, DTI, ASL
Medical subject headings
Alzheimer Disease, Dementia, Vascular, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega 3 PUFADrug

    Also called Fish Oil

    fish oil concentrate standardized to long chain n-3 PUFA content

  • PlaceboDrug

    Also called Soybean Oil

Study groups in NCT01953705
Study groupRoleWhat they receive
omega 3 polyunsaturated fatty acidsExperimental1.65 grams of EPA+DHA taken daily over 3 years
Receives: Drug: Omega 3 PUFA
Soybean oilPlacebo comparator1.65 grams of soybean oil taken daily over 3 years
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total cerebral white matter hyperintensity volume

    quantitative MRI

    Measured: annual over 3 years

Secondary outcomes (4)

  1. biomarkers of endothelial health

    blood based

    Measured: annual over 3 years

  2. total brain atrophy

    quantitative MRI

    Measured: annual over 3 years

  3. medial temporal lobe atrophy

    quantitative MRI

    Measured: annual over 3 years

  4. ventricular expansion

    quantitative MRI

    Measured: annual over 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2013 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2020 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01953705
Sponsor's protocol ID
R01AG043398
Other IDs
R01AG043398-01A1
Status last verified
Sep 2020
First submitted
24 Sep 2013
Last updated
4 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bowman GL, Dayon L, Kirkland R, Wojcik J, Peyratout G, Severin IC, Henry H, Oikonomidi A, Migliavacca E, Bacher M, Popp J. Blood-brain barrier breakdown, neuroinflammation, and cognitive decline in older adults. Alzheimers Dement. 2018 Dec;14(12):1640-1650. doi: 10.1016/j.jalz.2018.06.2857. Epub 2018 Aug 14.

    PubMed 30120040

  • Alber J, Alladi S, Bae HJ, Barton DA, Beckett LA, Bell JM, Berman SE, Biessels GJ, Black SE, Bos I, Bowman GL, Brai E, Brickman AM, Callahan BL, Corriveau RA, Fossati S, Gottesman RF, Gustafson DR, Hachinski V, Hayden KM, Helman AM, Hughes TM, Isaacs JD, Jefferson AL, Johnson SC, Kapasi A, Kern S, Kwon JC, Kukolja J, Lee A, Lockhart SN, Murray A, Osborn KE, Power MC, Price BR, Rhodius-Meester HFM, Rondeau JA, Rosen AC, Rosene DL, Schneider JA, Scholtzova H, Shaaban CE, Silva NCBS, Snyder HM, Swardfager W, Troen AM, van Veluw SJ, Vemuri P, Wallin A, Wellington C, Wilcock DM, Xie SX, Hainsworth AH. White matter hyperintensities in vascular contributions to cognitive impairment and dementia (VCID): Knowledge gaps and opportunities. Alzheimers Dement (N Y). 2019 Apr 9;5:107-117. doi: 10.1016/j.trci.2019.02.001. eCollection 2019.

    PubMed 31011621

  • Dayon L, Cominetti O, Wojcik J, Galindo AN, Oikonomidi A, Henry H, Migliavacca E, Kussmann M, Bowman GL, Popp J. Proteomes of Paired Human Cerebrospinal Fluid and Plasma: Relation to Blood-Brain Barrier Permeability in Older Adults. J Proteome Res. 2019 Mar 1;18(3):1162-1174. doi: 10.1021/acs.jproteome.8b00809. Epub 2019 Feb 15.

    PubMed 30702894

  • Bowman GL, Dodge HH, Guyonnet S, Zhou N, Donohue J, Bichsel A, Schmitt J, Hooper C, Bartfai T, Andrieu S, Vellas B; MAPT/DSA Study Group. A blood-based nutritional risk index explains cognitive enhancement and decline in the multidomain Alzheimer prevention trial. Alzheimers Dement (N Y). 2019 Dec 28;5:953-963. doi: 10.1016/j.trci.2019.11.004. eCollection 2019.

    PubMed 31921969

  • Hooper C, De Souto Barreto P, Coley N, Causse E, Payoux P, Salabert AS, Cesari M, Andrieu S, Bowman GL, Weiner M, Vellas B. Cross-Sectional Associations of Total Plasma Homocysteine with Cortical beta-Amyloid Independently and as a Function of Omega 3 Polyunsaturated Fatty Acid Status in Older Adults at Risk of Dementia. J Nutr Health Aging. 2017;21(10):1075-1080. doi: 10.1007/s12603-017-0989-x.

    PubMed 29188863

  • Bowman GL, Dodge HH, Mattek N, Barbey AK, Silbert LC, Shinto L, Howieson DB, Kaye JA, Quinn JF. Plasma omega-3 PUFA and white matter mediated executive decline in older adults. Front Aging Neurosci. 2013 Dec 16;5:92. doi: 10.3389/fnagi.2013.00092. eCollection 2013.

    PubMed 24379780

  • Bowman GL, Silbert LC, Dodge HH, Lahna D, Hagen K, Murchison CF, Howieson D, Kaye J, Quinn JF, Shinto L. Randomized Trial of Marine n-3 Polyunsaturated Fatty Acids for the Prevention of Cerebral Small Vessel Disease and Inflammation in Aging (PUFA Trial): Rationale, Design and Baseline Results. Nutrients. 2019 Mar 29;11(4):735. doi: 10.3390/nu11040735.

    PubMed 30934894

  • Shinto LH, Murchison CF, Silbert LC, Dodge HH, Lahna D, Rooney W, Kaye J, Quinn JF, Bowman GL. omega-3 PUFA for Secondary Prevention of White Matter Lesions and Neuronal Integrity Breakdown in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2426872. doi: 10.1001/jamanetworkopen.2024.26872.

    PubMed 39088212

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega 3 PUFA in people with Age Related Cognitive Decline and Alzheimer's Disease, run by Oregon Health and Science University 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 9 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 4 Sep 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

total cerebral white matter hyperintensity volume (time frame: annual over 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01953705, which also lists 8 linked publications.

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 4 Sep 2020.

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