Dominantly Inherited Alzheimer Network Trial: Primary Prevention (DIAN-TU-002)
Interventional Study
Get in touch about this studyFull study title: Dominantly Inherited Alzheimer Network Trial: Primary Prevention (DIAN-TU-002)
What is the study about?
To evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer’s disease (AD)-causing mutation. Stage 1 will determine if treatment with the study drug prevents or reverses amyloid beta (Aβ) accumulation compared with placebo in participants with dominantly inherited Alzheimer’s disease (DIAD). Stage 2 will evaluate the effect of early anti-amyloid treatment on downstream biomarkers of AD in treated participants compared to external control groups.
Eligibility – Who can participate?
Participants must:
- Be at least 18 years old
- Provide written informed consent, signed, and dated by the participant and study partner, or by the participant’s legally authorized representative if applicable, according to local regulations for the ICF and, if applicable, country specific ICFs.
- For people of childbearing potential (POCBP): a) Must have a negative serum pregnancy test at screening (V1); b) Must agree not to try to become pregnant during the study until 5 half-lives after the last dose of any study drug; c) Must agree not to breastfeed from the time of signed ICF until 5 half-lives after the last dose of any study drug; d) If partner is not sterilized, they must agree to use highly effective contraceptive measures (e.g., hormonal contraception, intra-uterine device, sexual abstinence, vasectomized partner) from screening (V1) until 5 half-lives after last dose of any study drug. Refer to the Global Manual of Operations for acceptable methods of contraception.
- Mutation status: a) Participant is a carrier of a mutation in an APP, PSEN1, or PSEN2 gene that is associated with DIAD OR does not know their mutation status AND there is a mutation in their family pedigree that puts them at a direct risk of inheriting the known mutation; AND b) Participant is between -25 to -11 years from predicted age of cognitive symptom onset based on their mutation type or family pedigree (refer to Global Manual of Operations for calculation of estimated age at onset). Note: If the at-risk parent is deemed a non-carrier through confirmed genetic testing at any time during the study, the participant will be withdrawn.
- Cognitive status of participant is normal (CDR-SB 0).
- Fluency in DIAN-TU trial approved language and evidence of adequate premorbid intellectual functioning. Participants must be fluent in languages for which cognitive and clinical measures have been translated and validated for use in the DIAN-TU. Fluency is generally defined as daily or frequent functional use of a language generally from birth or a young age. In cultures where multiple languages are spoken or for participants who are multilingual, determination as to whether a participant’s level of fluency in languages for which clinical and cognitive measures are available meets qualification for the study should be made by the site PI.
- Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
- Receiving stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to baseline visit (V2) with the exceptions of medications taken for episodic conditions (e.g., migraine abortive therapy, antibiotics, and other medications for upper respiratory and gastrointestinal ailments).
- Has a study partner who in the PI’s judgment can provide accurate information as to the participant’s cognitive and functional abilities, who agrees to provide information at the study visits that require study partner input for scale completion. Study partner must also be willing and able to sign the ICF, if applicable.
- Agrees not to donate blood or blood products for transfusion from the time of screening (V1) for a study drug arm, for the duration of the study, and for 5 half-lives after the final dose of study drug.
- In the opinion of the PI, the participant will be compliant and have a high probability of completing the study.
- Willing to complete all study-related testing, evaluations, and procedures.
Time requirement
Stage 1 is minimum 2 years and can last up to 5 years; If the participant is eligible to move forward to stage 2, it will be an additional 4 years. Total number of years of commitment for two stages would be 9 years.
Compensation/reimbursement: $45 CAD for every home visit or safety MRI; $195 and up to $780 CAD for all baseline and annual visits which are 3-4 days long
TDRA study investigator
Dr. Mario Masellis
More information
ClinicalTrials.gov ID: NCT05552157
TDRA Site:
Sunnybrook Health Sciences Centre,
Address: 2075 Bayview Ave, Toronto, ON M4N 3M5
