Alzheimer Disease (AD)DINOSENCT07237958
Effects on the Olfactory Epithelium and the Olfactory Nerve From Exposure to Diesel Exhaust
A study testing Diesel Exhaust Particles and Filtered air in people with Alzheimer Disease (AD) and Dementia Alzheimer Type, run by Umeå University at 1 site in Sweden.
Trial summary
The goal of this study is to study the effect exposure to air pollution and its effect on development of dementia. Does the diesel exhaust change the function of the olfactory system? Have the exposures measurable effects on the sense of smell and cognitive ability? Forty people are exposed to diesel exhaust exhaust… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease (AD), Dementia Alzheimer Type, Air Pollution Exposure
- What is being tested?
- Diesel Exhaust Particles and Filtered air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2019to 19 May 2023
- Phase
- Interventional
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- non-smoker
Who cannot join
- Allergic rhinitis
- Asthma
- Diabetes mellitus
- Kidney or liver failure
- Angina pectoris or previous ventricular arrhythmia
- Systolic blood pressure >190 mmHg or <100 mmHg
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- Previous blood disease
- Blood donation in the last three months prior to study start
- Previous or ongoing tobacco smoking and exposure to air pollution in the workplace
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on the Olfactory Epithelium in the Nose and the Olfactory Nerve (Nervus Olfactorius) From Exposure to Diesel Exhaust
The goal of this study is to study the effect exposure to air pollution and its effect on development of dementia.
Does the diesel exhaust change the function of the olfactory system?
Have the exposures measurable effects on the sense of smell and cognitive ability?
Forty people are exposed to diesel exhaust exhaust and filtered air. The exposures are blinded and in a randomized order. Both groups undergo biopsies of the olfactory epithelium in the nose under local anesthesia after the exposures and after performing cognitive test.
- Being tested
- Diesel Exhaust Particles, Filtered air
- Keywords
- cognitive function, Alzheimer Disease, Diesel Exhaust, Olfactory nerve
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diesel Exhaust ParticlesOther
During exposure to diesel exhaust, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale.
Filtered airOther
During exposure to filtered air, participants alternate between 15-minute periods of rest and exercise on an ergometer cycle with a workload that results in a minute ventilation of 20L/min/m² body surface area. Symptom recording is done every 30 minutes, following a routine based on a modified Borg scale
| Study group | Role | What they receive |
|---|---|---|
| Exposure to diesel exhaust | Active comparator | The participants will be exposed in an exposure chamber for diesel exhaust in a concentration of 300 µg/m³ for one hour. Receives: Other: Diesel Exhaust Particles |
| Exposure to filtered air | Placebo comparator | The participants will be exposed in an exposure chamber to filtered air for one hour. Receives: Other: Filtered air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diesel exhaust causes cellular dysfunction of the olfactory system
RNA sequencing and DNA methylation will be conducted to identify biomarkers for acute exposure to diesel exhaust.
Measured: 3 years.
Secondary outcomes (1)
Cognitive test
Olfactory function well be evaluated by using "sniffin' sticks," and a Letter-Digit Substitution Test as a marker for cognitive processing speed.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Feb 2019
- Primary completion12 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease (AD)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Umeå, University of Eastern Finland, Czech Academy of Sciences
- Responsible party
- Principal investigator, Ala Muala, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237958
- Sponsor's protocol ID
- 2018-438-31
- Other IDs
- x
- Acronym
- DINOSE
- Status last verified
- Nov 2025
- First submitted
- 4 Jul 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martikainen MV, Aakko-Saksa P, van den Broek L, Cassee FR, Carare RO, Chew S, Dinnyes A, Giugno R, Kanninen KM, Malm T, Muala A, Nedergaard M, Oudin A, Oyola P, Pfeiffer TV, Ronkko T, Saarikoski S, Sandstrom T, Schins RPF, Topinka J, Yang M, Zeng X, Westerink RHS, Jalava PI. TUBE Project: Transport-Derived Ultrafines and the Brain Effects. Int J Environ Res Public Health. 2021 Dec 28;19(1):311. doi: 10.3390/ijerph19010311.
PubMed 35010571