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New treatment option for Alzheimer's Disease (AD)
Official title An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease
ClinicalTrials.gov ID: NCT07724132
What this study is testing
What is Atomoxetine?
Atomoxetine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alzheimer's disease (ad).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A multicentre, interventional, multi-arm, multi-stage Phase 3 trial including randomisation, double blinding, placebo control evaluation of treatments for sustained clinical response (18 months) in symptomatic Alzheimer's Disease in a population representative of people with Alzheimer's disease in the UK.
- Phase 3: a large, late-stage study
- Time commitment: about 18 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Patient meets all 1\. Adults aged ≥55 years on the day of screening, no upper age limit 2. Either:
- Confirmed clinical diagnosis of Alzheimer's Disease (AD)
- Confirmed clinical diagnosis of Mixed Dementia consisting of Alzheimer's Disease and Vascular Dementia 3. Mini Mental State Examination score of ≥17...
- Pacemakers or defibrillators (unless MRI-conditional models)
- Aneurysm clips, stents or metal implants (unless MRI safe)
You likely can't join if
- Patient meets none of the exclusion criteria:
- Fazekas Score =3 reported from an MRI taken at any time prior to randomisation, if an MRI is not clinically contraindicated (reasons specified in...
- Clinical diagnosis of Dementia with Lewy bodies
- Clinical diagnosis of Parkinson's disease
- Clinical diagnosis of Frontotemporal Dementia
- Cardiac failure (American Heart Association Stage C or D)
See the full eligibility criteria
- Patient meets all 1\. Adults aged ≥55 years on the day of screening, no upper age limit 2. Either:
- Confirmed clinical diagnosis of Alzheimer's Disease (AD)
- Confirmed clinical diagnosis of Mixed Dementia consisting of Alzheimer's Disease and Vascular Dementia 3. Mini Mental State Examination score of ≥17 4. Confirmatory blood biomarker testing (pTau-217) (positive or...
- Pacemakers or defibrillators (unless MRI-conditional models)
- Aneurysm clips, stents or metal implants (unless MRI safe)
- Cochlear implants (unless MRI-conditional models)
- Metal fragments in the body
- Severe claustrophobia 8. Negative pregnancy test ≤4 weeks prior to randomisation for women of child-bearing potential 9. Normal liver function at screening consisting of all the following:
- Total serum bilirubin \<1.5 x ULN (except for participants with Gilbert's disease, for whom the upper limit of total serum bilirubin is 51.3 μmol/l or 3mg/dl)
- Alanine aminotransferase (ALT) \<3 x ULN;
- Alkaline phosphatase \
- For participants being re-assigned by chance after completing 18 months' follow-up and the arm was not closed due to lack of activity, a 12-week washout period from last dose of IMP must be completed before their...
- For participants being re-assigned by chance following treatment arm termination due to lack of activity, a 6-week washout period from their last dose of IMP must be completed prior to screening assessment Study Partner
- Participant that meets the AD-SMART eligibility criteria has consented to participation in the trial
- Has at least twice-weekly contact with participant
- Be 18 years or older at the time of providing consent
- Willing to complete study partner questionnaires as outlined in visit schedule
- Willing to attend remote and in-person study visits with participant
- Documented informed consent
- Patient meets none of the exclusion criteria:
- Fazekas Score =3 reported from an MRI taken at any time prior to randomisation, if an MRI is not clinically contraindicated (reasons specified in Inclusion Criteria 7) A. MRI does not need to be repeated if Fazekas...
- Clinical diagnosis of Dementia with Lewy bodies
- Clinical diagnosis of Parkinson's disease
- Clinical diagnosis of Frontotemporal Dementia
- Cardiac failure (American Heart Association Stage C or D)
- Significant respiratory comorbidity (hospitalisation within the previous ≤6 months due to respiratory comorbidity)
- Renal failure (CKD IV or eGFR ≤45 mL/min/1.73m²) at any time point prior to randomisation
- Malignancy (except if in complete remission) e.g. solid organ or haematological or melanoma
- Score of ≥1 on C-SSRS at screening visit
- Individuals without an identified study partner (refer to Section 4 for further details on study partners)
- Individuals who have an Alzheimer's Disease or Central Nervous System medication (e.g. antidepressant) change or dose change ≤28 days prior to screening
- Use of an Investigational Medicinal Product (IMP) or Investigational Medical Device (IMD) ≤26 weeks prior to randomisation (except for AD-SMART participants that are being re-assigned by chance. See Section 5.4 for...
- Receiving antibody-based amyloid clearing treatment for Alzheimer's Disease within 26 weeks prior to randomisation
- Unable or unwilling to comply with study procedures
- Unable to swallow whole capsules
- Individuals who are living in the same household as an AD-SMART participant who is actively taking trial medication
- Female participants that are pregnant or breastfeeding
- Women of child-bearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception (see acceptable methods of contraception) whilst on trial treatment and up to 12 weeks after the last...
- Male participants with a partner of child-bearing potential unwilling or unable to use an acceptable method of contraception whilst on trial treatment and up to 12 weeks after the last dose of the study drug.
- Male participants unwilling to desist from sperm donation during the trial and for 12 weeks after the last dose of trial treatment
- Current or previous exposure to any of the currently recruiting AD-SMART IMPs ≤26 weeks before randomisation.
- History of alcohol and/or drug abuse and/or dependence within the 5 years prior to screening visit.
- Any concurrent medical condition, abnormal laboratory tests or uncontrolled, clinically significant systemic disease that, in the opinion of the Investigator, could cause study participation to be detrimental to the...
- Participants who are not eligible for any of the trial IMPs, according to the eligibility criteria listed in the individual drug appendices. Please note that participants can enter the trial if they are eligible for at...
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
- Chertsey, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom; Chertsey, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.