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
- 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 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
Show all 10Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on the Olfactory Epithelium in the Nose and the Olfactory Nerve (Nervus Olfactorius) From Exposure to Diesel Exhaust
- ClinicalTrials.gov ID
- NCT07237958
- Acronym / sponsor ID
- DINOSE / 2018-438-31
- Keywords
- cognitive function, Alzheimer Disease, Diesel Exhaust, Olfactory nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Umeå, University of Eastern Finland, Czech Academy of Sciences
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 20 Nov 2025 (actual)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure to diesel exhaust | Active comparator | Other: Diesel Exhaust ParticlesThe participants will be exposed in an exposure chamber for diesel exhaust in a concentration of 300 µg/m³ for one hour. |
| Exposure to filtered air | Placebo comparator | Other: Filtered airThe participants will be exposed in an exposure chamber to filtered air for one hour. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy
- non-smoker
Key exclusion criteria (10 listed)
- Allergic rhinitis
- Asthma
- Diabetes mellitus
- Kidney or liver failure
- Angina pectoris or previous ventricular arrhythmia
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 |
|---|---|---|
| Diesel Exhaust ParticlesDuring 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. | Other | Exposure to diesel exhaust |
| Filtered airDuring 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 | Other | Exposure to filtered air |
Primary outcome
Diesel exhaust causes cellular dysfunction of the olfactory system
Time frame: 3 years.
RNA sequencing and DNA methylation will be conducted to identify biomarkers for acute exposure to diesel exhaust.
1 secondary outcome
Cognitive test
Time frame: 3 years
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 20 Nov 2025.
- Background: PubMed 35010571Martikainen 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.
- ADAIR websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 2 inclusion and 10 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 20 Nov 2025. 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 Sweden. 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.
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?
Diesel exhaust causes cellular dysfunction of the olfactory system (time frame: 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 NCT07237958, which also lists 1 linked publication.
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 20 Nov 2025.